?o??eo 374,33. UNITED STATES ENVIRONMENTAL. PROTECTION AGENCY 3 WASHINGTON. D.C. 20460 "3 ?5 2 6a? Pnoie FEB 2 wt, Ms. Diane Hebert Greenpeace International 2505 E. Segnet Court Midland, MI 48640 Dear Ms. Hebert: Because of your interest in the Environmental Protection Agency's dioxin activities. we want to notify you that EPA is transmitting an information collection request package to the Office of Management and Budget (OMB) for approval as required under the provisions of the Paper? work Reduction Act. This action is necessary before EPA can initiate a cooperative agreement with the U.S. pulp and paper industry to obtain dioxin data at all the U.S. pulp and paper mills which bleach pulp with chlorine or chlorine derivatives. A copy of the Federal Register notice announcing this transmittal is enclosed. He are also sending you a fact sheet summarizing the details of this study and the information collection request package which includes a copy of the cooperative agreement as an appendix. As noted in the Federal Register, comments on this activity should he sent to OMB and to EPK. If youahave questions on this data gathering activity or would like to meet with our staffs to discuss the cooperative agreement, please call Tom O'Farrell at (202)382?7137. Sincerely, William A. Hhittington Charles Elkins Director Director Office of Water Regulations Office of Toxic Substances and Standards Enclosures UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 5? WASHINGTON. o.c. 20450 OFFICE OF WATER Mr. Tim Hunt Desk Officer Office of Information and Regulatory Affairs Office of Management and Budget 726 Jackson Place, N.H. Washington, 0.0. 20503 Dear Mr. Hunt: Enclosed please find an Information Collection Request which we are transmitting to you under the provisions of Section 3507 of the Paperwork Reduction Act. As a result of a dioxin study at five bleached kraft pulp mills, EPA determined that additional data should be collected to characterize the levels of dioxin discharged from the 105 U.S. pulp and paper mills which bleach pulp with chlorine or chlorine derivatives. This data collection activity would be carried out through a cooperative agreement with the 0.5. pulp and paper industry. Because of the need to proceed with the collection of information quickly, we request that you give this information collection activity an expedited review. . In addition to supplying the dioxin data from 105 mills, the industry has agreed to conduct a more intensive study at a subset of the facilities, approximately 25-30 mills (please see paragraphs 3.4 and 3.5 of the attached Cooperative Dioxin Study). My staff was unable to calculate at this time the burden on the industry resulting from this intensive study since the industry's study plan is still being developed. Therefore, an amended supporting statement reflecting the added burden and costs associated with the intensive study will be sent to you after the industry's intensive study plan is completed. If you have any questions, please feel free to call Tom O'Farrell of my staff at 382-7137. Sincerely, Hilliam A. Whittington Director Office of Hater Regulations and Standards Enclosure ?5 StandardFormaa RequeSt 'or OMB Hewiew (Rev September 1983) Important Read instructions before completinf form. 00 not use the same SF 83 Send three copies of this form. the material to be reviewed, and to reguest both an Executive Order 2291 renew and approval under paperwork?three copies of the supporting statement. to. the Paperwork Reduction Act Answer all questions in Part I. It this request is tor review under {5 0 Office oi Information and Regulatory News 12291. complete Part II and sign the regulatory certi?cation II this of Managementand Budget feQuest is tor approval under the Paperwork Reduction Act and 5 CF Attention Docket Library. Room 3201 1320 SKID Pad ll. complete Part in and sign the paperwork certification Washington. DC 20503 PART l.?Complete This Part tor All Requests. 1. Department/agency and Bureau/ottice originating request 2. Agency code Environmental Protection Agency, Office of Water 3 1i_ 3. Name of person who can best answer questions regarding this reQuest Telephone numt-iei Thomas P. O'Farrell (NH-552) 202 I 382?7137 4. Title at Information collection or rulemaking Study on Dioxin Formation During Bleaching of Pulp 5. Legal authority tor Information collection or rule (Cite United States Code Puoiic Law. 0r Executive Order) _3_3__usc ?1,318 23c: and 15 USC ?2605 6.M?iected public (check 5 ederalagencues or employees 1 individuals or households 3 Farms 6 Non-profit institutions 2 State or localgovernrnents 4 Businesses or other tor-profit 7 Smallbusrnesses ororganizat-on: PART This Part Only If the Request is for OMB Review Under Executive Order 12291 7. RegulatIOn Identitier Number (RIN) NoneassigneoD I. Type 01 submission (check one In each category) l'ype a! review requested Classification Stage oIdeveiopment 1 Standard 1 Maior 1 [3 Proposed or draft 2 Pending 2 Nonmaior 2 3 Emergency 3 Finalorinterimfinai.mmoulwm' 4 Statutoworiudicnldeadline 9. CFR section atteclec CFR 10. Does this regulation contain ireporting or Irecordlieepingi require OMB approval under the Paperwork Reduction Act . . . . .D Yes ll. Itemaiorrule . . . . . . . . . . . . . . . . . . . . . Yes 2 - - - -3DYes 4: Certification for Regulatory Submissions Ii In submitting this request for OMB renew. the authorized regulatory contact and the program otticial unity um the requirements of 0 12291 and any apolica: policy directives have been complied with Signature ot program o?icial Date Signatureo authorized regulatory contact Date 12. (6MB use only) 13. Abstract?Describe needs. uses and altected publrc 1h 50 words or less ornplete This Part Only If the Request ls lor Approval of a Collection of Information Under the Paperwork Reduction Act and 5 CFR 1320. Water pollution, wastes. wood pulp, toxic substam This study will request information on the formation of dioxins/forms during the bleaching of Chmlul l"0?C! PUIP from 105 pulp mills. EPA will use the information to assess the need for regulations modify NPDES permtt and characterize the full range of risks inposed by dioxin in bleached wood pulp. 14. Type of rntorrnatron collect-on (chect only one) Intonation de?ection-rs not centalnedln rules 1 Regular Information collections contained in rules 3 {stating regulation (no change proposed) 4 Home of proposed ruler'nalung (NPRM) 5 was prevrously 2 EmergenCy attached) 6 ?nal or Interrm frnal without pnor NPRM 7 Enter date of erpected or actual Federa? A Regular Reg-ster publrcalooh at thus stage of rulema?u-r? {mergency attached) d?J'r 15. Type of revrevv requested (check onry one) 1 New collectron 4 Reinstatement of a prevmusly approved collectron tor whuch approva' 2 Revtsron of a currently approved collection 3 Estensron ot the esprratron date of a currently approved 5 collectron use without an OMB control number any change In the substance on In the method 0' colleztnon 16. Agency report form number(s) {mclude standard/ophonal form numbera? 22. Purpose of Informal-on collection (check as many as app! if 3 a Apphcat-on for bene?ts 2 El Program evaluat-on 17. Annual or burden 3 General purpose ?mm? 1 Number 04 respondents . . 105 1 4 Regulatory or complrance 2 Number oi responses per respondent 1 1 5 Program p:ahnm? or management 3 Total annual responses (hoe 1 trmes lrne 2) 105 1 6 Research 4 Hours per response 320 1 500 7 ludll 5 Total hours (lane 3 tunes lrne 4) '3 080 II. Annual recordkeeprng burden 23. Frequency of recordkeepmg or reporting (check all that apply) 1 Number of recordheepers 106 1 Recordkeeplng 2 Annual hours per recorateeper 0. 5 Reporting 3 Total recordteep-ng hours (hne .I trmes lrne 2) 53 2 a On occaslon 4 Recordkeebrns 'etentuon 90"00 1 3 19. Total annual burden 1 Reduested (hoe 17-5 plus Quarterly 2 In current 0MB Inve?lOFy 0 6 Semi-annually 3 Drtterence (lane 1 less Irne 2) 3'5 '1 33 7 Annually Explanation of difference 8 Brenmally Prmram change '35 .1 9 Other 5 Adjustment . I I . 20. Current (most recent) OMB control number or comment number 24. Respondents donation to comply (check tnestrongesroohgahon tharapp'res 1 Voluntary 21. Requested espuahon date 2 Requrred to obtasn or retain a bene?t 2 vears from date of 3 Mandatou 25. Are the respondents educational agencoes or or rs the primary purpose ol the collection related to Federal education programs? Yes 26. Does the agency use to select respondents or does the agency recommend or prescnbe the use of sampling or statastrcal by respondents . . . . Yes 27. Regulatory authorrty tor the Informatuoh CFFI or FR Or, Other (specrry) ?apenrorlt Certification In this request for OMB approval the agency head the senior o?rcral or an authorized representatrve certrhes that the requrrements ol 5 CFR 1320 it Prrvacy Act.stat1st1cal standards or drrectwes and any other IDDllub'Q untormahon pohcy drrectuves have been compiled Sunature oi program Date A ?Qag 1-3?88 of agency head the semor or an authrzed representatuv! Date L) 2 54* if? RESEARCH ON DIOXIN FORMATION DURING THE BLEACHING 0F HOOD PULP SUPPORTING STATEMENT A. JUSTIFICATION 1. Need for the Information Collection BACKGROUND The fonnation of dioxins and furans in the bleaching of wood pulp is of concern to the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC), and the U.S. Food and Drug Administration (FDA) because of these compounds' high toxicity. dioxin (2378-TCDD) has demonstrated a variety of toxic effects (including death, carcinogenicity, teratogenicity and inmunotoxicity) in acute and chronic exposure studies of animals. Much less infonnation is available on the effects of exposure to chlorinated dioxins and furans in humans. 237B-TCDD is considered a probable human carcinogen under EPA's classifica- tion scheme. In addition, dioxins are extremely persistent in the environment, with degradation processes estimated to have half-lives of ten years or longer. A more detailed discussion of chemical properties and toxicological characteristics may be found in the introduction (Section I) to EPA's National Dioxin Study. The U.S. EPA National Dioxin Study was a two-year multimedia, nationwide evaluation of dioxin (2378-TCDD) contamination initiated at the request of Congress. Sites targeted for investigation were 2.4.5-trichlorophenol (245-TCP) production, use and application sites, waste diSposal facilities, and combustion sources. Ambient environmental monitoring stations were also sampled to obtain background dioxin level data. The objectives, organization, and reSults of this study are discussed in an executive summary and introduction to the National Dioxin Study (Attachment A). The National Dioxin Study confirmed not only the contamination of soils near 245-TCP production, use and application sites but also the formation of chlorinated dioxins and furans in some incinerators. Analysis of fish tissue from 395 collection sites revealed 2378-TCDD contamination at 112 (28 percent) of the sites. Fish contamination was associated with chemical industry activity and pulp and paper industry discharges. 2378-TCDD was detected in fish samples at 57 percent (16 of 28) of the sites sampled of pulp and paper mills. Data on pollutant levels in pulp and paper industry wastewaters available from NPDES permit applications and discharge monitoring reports are limited to average and maximum loads of conventional pollutants (T58, 8005). Data on nonconventional and toxic pollutant loads are available from only a portion of all U.S. pulp and paper mills. Specific monitoring requirements or limitations for dioxins are not included in any pulp and paper mill NPDES or pretreatment permits. Sampling and analysis for dioxins and furans were not conducted in past effluent guidelines data collection programs. -2- As a follow-up to the National Dioxin Study findings, EPA obtained information from five bleached kraft pulp mills indicating that 2378-TCDF (tetrachlorodibenzofuran) are present in the effluents, sludges and pulps from these facilities. The data on dioxin levels in effluents, sludges, and pulps and detailed process information from the five bleached kraft pulp mills were obtained through a cooperative agreement with the American Paper Institute (API) and the National Council of the Paper Industry for Air and Stream Improvement, Inc. (NCASI). This agreement was signed in June, 1986 and was titled "The U.S. EPA/Paper Industry Cooperative Dioxin Screening Study." Sampling of the five mills (located in Ohio, Oregon, Maine, Minnesota, and Texas) was started in June, 1986 and continued through January, 1987. Analytical work was delayed due to extensive methods development work and was completed in November, 1987. Improvements in analytical methodologies now make it feigible to detect dioxins/furans at the parts per quadrillion or (10' range in liquid matrices and the parts per trillion or (10? range in solid matrices. The final report is expected in February, 1988. Major findings of the U.S. EPA/Paper Industry Cooperative Dioxin Screening Study are: 2378-TCDD was detected in seven of nine bleached pulps (ND-51 ?ppt), three of five treated effluents (ND-0.12 ppt), and five of five wastewater sludges (3.3-180 ppt) Paper mill discharges of 2378-TCDD are approximately 2.5 to 15 times higher than the average discharge from Dow Chemical's Midland, Hichigan plant before additional treatment was installed by Dow Chemical. There appears to be a relationship between the degree of bleaching and the formation of 2378-TCDD and 2378-TCDF. After reviewing the results from the c00perative study at the five mills, .EPA consulted with the CPSC and FDA to determine what actions would be taken. The following additional data needs were identified. The Office of Hater Enforcement and Permits (OHEP) needs data on dioxin and furan levels in pulp mill effluents and sludges for use in NPDES permit modifications. The Office of Hater Regulations and Standards Industrial Technology Division is beginning a review of pulp and paper industry effluent guidelines. The develOpment of additional effluent limitations for dioxins and furans is under consideration. The Office of Solid Haste (OSH) is currently reviewing land application and other disposal methods for dioxin-contaminated sludges. Data on dioxin levels and sludge diSposal practices of pulp mills is needed to evaluate the hazards associated with mill sludge diSposal. The Office of Toxic Substances (OTS), the Consumer Products Safety Commission (CPSC), and the U.S. Food and Drug Administration (FDA), need data on dioxin levels in bleached wood pulps to estimate the degree of paper product contamination and the health risks associated with the use of contaminated paper products. Information is needed from all the approximately 90 bleached kraft pulp mills in the U.S. and from all the other mills that bleach pulp with chlorine or chlorine derivatives to characterize the formation and levels of dioxins at all pulp and paper mills bleaching chemical wood pulps. EPA, API and NCASI developed a joint agreement to study these facilities. I. -3- Additional sampling and analysis of the five mills already studied is not required under this data collection activity. Included in this cooperative agreement is an intensive study of 25 mills which may provide information on the relation of process variables to dioxin and furan formation. There is potential to extend this study of dioxin/furan formation to other industries that use chlorine in their processes and may also generate dioxins/furans. AUTHORITY Authority to collect the information required under this activity is contained in ?308 of the Clean Hater Act and ?6(b)l of the Toxic Substances Control Act. In addition, 40 CFR states that new information is cause for permit modification. Also, 40 CFR states that additional data collection may include information needed to assess the toxicity of a facility's discharge and to determine the cause of the toxicity. Relevant portions of NPDES regulations and the above referenced authorizations to collect information are attached (Attachment B). An existing ICR (0MB 2040-0068, expires 11/30/88) covers information collection for permit modifications. Permit modification infonmation requests have been incorporated into this ICR along with the information requests of other EPA offices (OHRS, OTS. 05H) and other federal agencies (CPSC, FDA) to consolidate all federal data acquisition activities regarding dioxin formation at pulp and paper mills. The paper industry (API, NCASI, and all participating mills) have agreed to voluntarily provide EPA with all of the infonmation EPA has set forth in the attached study agreement (Attachment C). Specific sampling, analytical and reporting protocols to be followed in data collection have been discussed among representatives from EPA's Office of Hater and Office of Toxic Substances, API, NCASI and several bleached kraft pulp mills. EPA intends to use a ?308 letter to formally require the same information described in the study agreement from any participating mill that does not fully comply with the agreement in a timely manner. 2. Description and Practical Utility of the Information Collection Activity The ICR Activity Respondents are the National Council of the Paper Industry for Air and Stream Improvement, Inc. (NCASI) and an estimated 90 bleached kraft pulp mills and 15 additional mills using chlorine to bleach wood pulp in about 27 states. Respondents must I. Submit existing analytical results for dioxins/furans in wastewaters, sludges, pulps, process raw materials or additives, and any environmental media river sediments, fish tissue). (Paragraph 2.3, Attachment C) -4- 2. Provide flow and analytical measurements of treated process wastewater for a one-year period (October 1986 - September 1987). This applies for information not previously submitted to Regions/States in any CHA Submission. (Attachment C: paragraph 2.1 and paragraph 1 of Attachment 3) 3. Provide schematic of existing wastewater treatment system if it is different from what has previously been supplied to Regions/States in any CHA submission. (Attachment C: paragraph 2.1 and paragraph 1 of Attachment 3) 4. Provide a one page summary of current sludge diSposal practices and sludge disposal practices over the past ten years. Provide estimates of sludge amounts generated for a one year period. (Attachment C: paragraph 2.1 and paragraph 2 of Attachment 3). 5. Submit specific technical information on each bleach line within the plant. (Paragraph 2.1 and Attachment 1 of Attachment C). 6. Sample (5-day composite. individual daily composites) and obtain analyses on effluent, sludge and pulp from each bleach line within the plant. Submit results of analyses to EPA. Provide information for the 5-day period when samples were collected. (Attachment C: paragraph 2.2, paragraph 3.6 and Attachment 2) 7. NCASI will provide quarterly progress reports of the industry's ongoing research into the causes and significance of dioxin formation in the bleaching process. (Paragraph 3.12 of Attachment C) EPA will provide detailed information on the methods of sample collection and analytical methodologies for required chemical analyses to the reSpondents. EPA Headquarters will transmit data to the appropriate Region/State for their consideration of existing NPDES/pretreatment permit modifications. EPA will evaluate wastewater information for use in developing amendments to existing pulp and paper industry effluent guidelines. EPA will evaluate all information to detennine environmental and human health impacts, exposure routes, and associated health risks. EPA's Use of the Data OHEP's permitting strategy for dioxin discharges from pulp and paper mills recommends the implementation of best management practices (BMPs) and the development of water quality-based dioxin effluent limitations for all bleached kraft pulp mills. In most cases, water-quality based - limitations will be below current analytical detection limits due to EPA's most conservative estimate of dioxin potency. OHEP will encourage Regions/States to use data on dioxin levels in industrial effluents to determine best management practices, compliance schedules, or final dioxin effluent limitations as appropriate for each bleached kraft pulp mill. OHEP has identified mills whose NPDES permits have expired or will expire in 1988 for priority investigation under the dioxin mi -5- study. The new information on dioxin levels at other facilities will be used to reapen and modify NPDES permits to include dioxin limitations. compliance schedules, and BMPs as deemed necessary to protect water quality. The Industrial Technology Division is beginning a review of existing pulp and paper industry effluent guidelines (40 CFR Part 430). The information collected through the cooperative dioxin study will potentially be used to develop additional effluent limitations for dioxin in pulp and paper mill bleach plant wastewaters. Detailed process information may provide insight into possible control and treatment technologies. DTS will use the data from the study to help support an inter-agency risk assessment effort intended to characterize the full range of risks imposed by dioxin formation in bleached wood pulp. Listing of Data Items and Reporting Frequencies All infonmation to be supplied and reporting requirements are detailed in the attached U.S. EPA/Paper Industry Cooperative Dioxin Study. The cooperative study is a one time data collection activity. Further data collection may occur on reapplication for NPDES penmits (Form 2C). 3. Use of Improved Information Technology to Minimize Burden The specific information is necessary from each facility; therefore. it is not possible to reduce burden significantly. The respondents do not have to submit information if the information has already been submitted under the CHA. 4. Non-Duplication This data collection activity has been developed in coordination/consultation with other offices within EPA Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA). Information requested in this activity does not duplicate any of these organizations' independent data collection activities. Information received as a result of this activity will be shared with other federal agencies and EPA offices. In almost all cases, the currently available data contained in existing NPDES application (Form 2C. OMB 2040-0086) and discharge monitoring report (0MB 2040-0004) forms do not indicate the presence of dioxin/furans due to the rapid improvement of analytical capabilities. Additional sampling and analyses are not required of the five mills studied under the U.S. EPA/Paper Industry Dioxin Screening Study as part of this data collection activity. [e 5? "x -5- 5. 'gonsiggratiqn_gf_Alternatives EPA believes that the dioxin/furan infonmation being requeSted is not currently available. Consequences of not collecting the data include the potential for inconsistent permitting activities and a lack of information to establish additional effluent limitation guidelines. EPA staff have had numerous discussions on the best method (5308 letter. TSCA action. or cooperative study) of collecting the required information (Attachment D). Obtaining the information through a cooperative study was chosen since all parties involved felt that more infonmation of better quality would be obtained faster than under a ?308 letter to 105 individual mills. Some information will he provided voluntarily by the fatilities which they might otherwise argue may not be subject to 5308 authority. 6. Minimizing of Burden for Small Businesses Very few, if any. of the respondents are small businesses. The 105 mills subject to this activity represent 42 corporations. Seventeen of these 42 corporations are ranked in the top 20 U.S. paper mills in sales according to the 1987 Lockwood's Directory of the paper and allied trades. Eight of the remaining 25 corporations operate only one mill. Production at these eight mills range from 100 tons pulp/day to 1700 tons pulp/day. 7. Consideration of Less Frequent Collection The information collection activity is a one time effort. 8. Paperwork Reduction Guidelines Some of the reSpondents may submit claims of confidentiality on process information. The claims will be handled according to existing Agency procedures and regulations as specified in 40 CFR Part 2, Subpart B. None of the provisions in 5 CFR 1320.6 are exceeded. Within 15 days of the effective date of the agreement. NCASI is to assign a unique mill code number to each mill identified in Attachment 4 of the cooperative study agreement. Also within 15 days, is required to provide EPA with a list of the mill code numbers and the identity and location of the mills which they represent. This is necessary since all data will be reported by mill code number and some initial data reports are to be provided within 30 days of the effective date. To avoid any further delays in reporting and since all participating mills have already been identified, EPA believes that 15 days is sufficient time for NCASI to provide mill code information. 9. Consultations EPA staff have a good professional working relationship with the paper industry. specifically API and NCASI. EPA and have worked together successfully on the previous study at five bleached kraft pulps' mills. As soon as-positive results for dioxins/furans were found in pulps, effluents and sludges of the five mills (August, 1987) and EPA began to separately discuss what the industry and the Agency felt were the next obvious steps. Similarities between EPA's additional data needs_ nI-r . - -7- identified and plans for industry studies led the three organizations into discussions of another EPA and paper industry cooperative study. EPA staff have consulted with representatives from the CPSC, U.S. FDA. API, NCASI and several member companies on numerous occasions (October 1987-January 1988) to develop the attached EPA/Paper Industry Cooperative Dioxin Study agreement. We were able to develOp this agreement with the paper industry because of a shared concern over the dioxin problem and a mutual recognition that a cooperative effort would be the quickest and most efficient approach to investigating the possible sources of dioxin. 10. Confidentiality EPA and any EPA contractor will treat all information for which a claim of confidentiality has been asserted in accordance with the procedures of 40 CFR Part 2. Subpart B. Claims of confidentiality may not be asserted for analytical data on treated or untreated wastewater or wastewater treatment sludge. 11. Sensitive Questions There are no sensitive questions included in this ICR. 12. Cost to the Government and to the Respondent Cost to the Federal Government Data analysis and interpretation 1080 hours $22,000 (includes documentation and review of data received and issuance of summary reports) Penmit modification evaluations 592 hours $19,000 (33 EPA issued permits, 8 hours each plus support for state review of the remaining 82 permits) Effluent guidelines review 400 hours $15,000 (Review and analysis to determine BAT standards and potential control/ treatment technologies plus support to States/Regions) Evaluation of health risks associated 400 hours $15,000 with paper product use . Total 2472 hours $71,000 - 31$ -8- Estimated Cost to the Respondents Individual Mill Cost Sampling . 500 (includes sample containers and equipment, shipping and storage) Chemical Analyses 9 samples $1200/each $10,800 Labor 320 hours $40/hour $12,800 Total 24,100/mill Industry Costs Total Mill Cost 105 mills $24,100/each $2,530,500 NCASI Technical Support 1500 hours S40/hour 60,000 Analysis (Attachment C: paragraph Duplicates and matrix Spike analyses for 10 percent of all samples 189 samples $1200/each 226,800 Total Homologue Analysis (Attachment C: paragraph 5 42,000 35 samples $1200/each Inter-laboratory comparability study (Attachment C: paragraph 2 labs participating. 27 split samples 54 samples 0 $1200 each 64,800 Total Cost to Industry: $2,924,100 gen 1) -9- 13. Estimation of Respondent Burden Reporting a) submit existing dioxin/furan information 5 hours b) summarize 1986-87 effluent flow/analytical information 20 hours c) submit wastewater schematic diagram 5 hours d) submit sludge information 30 hours e) supply bleach plant information 160 hours process schematic diagram 20 hrs/line chemical application rates 20 hrs/line wood production information 5 hrs/line Operating parameters 20 hrs/line Kappa Number data 5 hrs/line GE Brightness data 5 hrs/line washing loss data 5 hrs/line assume 2 lines per plant f) sampling and analysis for preparation 24 hours (includes identifying sites, purchasing equipment. and miscellaneous cleaning) sampling (6 hrs/day. 10 days) 60 hours shipping (includes compositing, packing and shipping) 16 hours 320 hours/plant In addition, NCASI, acting as a clearinghouse for all of the information, 'will incur a small burden on time and resources. The extra burden anticipated for NCASI is approximately 1500 hours. Recordkeeping Respondents will be required to maintain a copy of their data submitted to EPA and any records that were used to develop their response for a period of one year. Time required to copy and file documents is only one- half hour per respondent. The total recordkeeping burden for industry as a result of this activity is 53 hours. 14. Reasons for Change in Burden This is a new data collection activity. -10- 15. Scheduling U.S. EPA/Paper Industry Cooperative Dioxin Study Effective Upon Signature Receipt of industry intensive study (25-30 mills) 30 days after effective workplan for EPA review date Receipt of all existing dioxin/furan information 150 days after effective date Receipt of all wastewater schematics 60 days after effective date Receipt of 1986-87 effluent data for all mills 60 days after effective date Receipt of all typical bleach plant information 120 days after effective date Receipt of sludge information 90 days after effective date Individual mill sampling for dioxin/furans Ongoing throughout 1988 Commence 30 days after effective date Receipt of Analytical Results for Dioxins/Furans beginning 60 days after start-up of sampling 7 Industry Comprehensive Report on Intensive Study No later than 60 days after receipt of all analytical data Industry Progress Reports on Research into Quarterly beginning causes and significance of dioxin formation 60 days after effective during bleaching date continuing for five quarters Information will be made available to the apprOpriate Regions/States through the Industrial Technology Division, OHRS (Tom O'Farrell, FTS 382?7137). We believe that the information to be provided should be sufficient to characterize dioxin generation at the covered mills and that regional 6308 letters will not be necessary to obtain the information Specified in the agreement. In view of lab capacity shortage and potential trade-offs in scheduling of work, EPA Headquarters asks that Regions inform Tom O'Farrell when planning any investigations of dioxin at pulp and paper mills. He will coordinate these regional activities with the national study. 16. Standard Industrial Classifications ;n I Respondents affected by this industry are included in SIC codes 26s}. 2621, 2631 and 2661. B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS Statistical methods or techniques were not used to develop the list of facilities covered by this activity. All pulp mills using chlorine or chlorine derivatives to bleach chemical wood pulp are included in the cooperative dioxin study. Sampling priorities were established considering a facility's permit expiration date and any recent dioxin contamination. data of fish of the mills. EPA believes that five-day composite samples of effluent, sludge and pulp are adequate to represent average performance of the mill and each bleach line. The analytical protocol provides for the analysis of duplicate samples (10 percent) and matrix Spikes (10 percent). In addition, an inter-laboratory comparison will be conducted at the outset of the study 'tb demonstrate that two or more laboratories are capable of providing comparable analytical results using the methodology provided by EPA. C. APPENDICES 1. National Dioxin Study executive smnmary and introduction 2. ?308 of CHA, ?6(b)1 of TSCA, relevant portions of NPDES regulations 3. U.S. EPA/Paper Industry Cooperative Dioxin Study- 4. Advantages/Disadvantages Summary of ?308 letter approach and Cooperative Study approach ATTACHMENT A NATIONAL DIOXIN STUDY EXECUTIVE SUMMARY AND INTRODUCTION INFORMATION COLLECTION AUTHORITY REGULATIONS shed under this ollutants into a be a new source Jtants. will not blished for any all promulgate such sources Of performance sources. Such any pollutant fare with. pass I or prohibition on. it shall be to operate any prohibition or atment Systems. to comply with 11s section by ants of section publicly owned such facility .e pretreatment tot to exceed 2 ive reel 1 ation with the a pretreatment '111 not cause olstion of its to contribute the proposed shall take of employees 3 effectively the Federal "131.- f- Sec. 306. Inspections. Honitoring and Entry. Whenever required to carry out the objective of this Act. including but not limited to (1) developing or assisting in the development of any effluent limitation. or other limitation. prohibition. or effluent standard. pretreatment standard. or standard of performance under this Act; (2) determining whether any person is in violation of any such effluent limitation. or other limitation, prohibition. or effluent .standard. pretreatment standard. or standard of performance: (3) any requirement established under this section; or carrying out sections 305. 311. ?02. 406 (relating to State permit programs). h05. and 504 of this Act -- (Sec. 308(a)(a) amended by PL 100-4) (A) the Administrator shall require the owner or operator of any point source to establish and maintain such records. (ii) make such reports. install. use. and maintain such monitoring equipment or methods (including where appropriate. biological monitoring methods). (iv) sample such effluents (in accordance with such methods. at such locations. at such intervals. and in such manner as the Administrator shall prescribe). and provide such other information as he may reasonably require; and (B) the Administrator or his authorized representative (including an authorized contractor acting as a representative of the Administrator). upon presentation of his credentials -- shall have a right of entry to. upon. or through any premises in which an effluent source is located or in which any records required to be maintained under clause (A) of this subsection are located. and (ii) may at reasonable times have access to and copy any records. inspect any monitoring equipment or method required under clause (A). and sample any effluents which the owner or operator of such source is required to sample under such clause. [Sec. 308(a)(5) amended by PL lOO-h] Any records. reports. or information obtained under this section (1) shall. in the case of effluent data be related to any applicable effluent limitations. toxic. pretreatment. or new source performance standards. and (2) shall be available to the public. except that upon a showing satisfactorv to the Administrator by any person that records. reports. or information or particular part thereof (other than effluent data). to which the Administrator has access under this section. if made public would divulge methods or processes entitled to protection as trade secrets of such person. the Administrator shall consider such record. report. or information. or particular portion thereof confidential in accordance with the purposes of section 1905 of title 18 of authorized representative of the authorized contractor Administrator) who discloses. or makes the United States Code. Any Administrator (including an acting as a re presentative of the ot more than an 1 year. or both. Nothing in this subsection shall prohibit the Administrator or an authorized representative of the Administrator (including; any authorized contractor acting as a representative of the Adainistratory) from disclosing records. reports. or information to other officers. employees. or authorized representatives of the United States concerned with carrying out this Act -or when relevant in any proceeding under this Act. [308(b) amended by PL 100-4) Each State may develop and submit to the Administrator procedures under State law for insp action. Ionitoring. and entry with respect to point sources located in such St Administrator finds that any State are applicable to at red by this section. such State nd enforce its procedures for i nonitoring. and entry State (except with respect to point sources owned or operated by the United States). (4) Access by Congress. Notwithstanding any limitati in this section or any or on contained her provision of law. all information reported to or otherwise obtained by the Administrator (or any representative of the Administrator) under this Act shall be made available. upon written request of any duly authorized committee of Congress. to such committee. [308(d) added by PL loo-a1 hm 5. Sec. 309. Federal Enforcement, - fSee also Section 318 of PL 100-4, for applicability of this Section Aquifer-Rockaway River Basin. published at the end of this Act. to the Unconsolidated Quarternary New Jersey I (1) Uhenever. on the basis of any information available to him. the Administrator finds that any person is in violation of any implements section 301. 302. 306. 30?. 308. 318. or 405 of this under an approved permit pro this Act. he shall proceed under his aut of this subsection or he shall notify the person in alleged Violation and such State of such finding If beyond the thirtieth day after the Administrator? has not commenced appropriate Administrator shall issue an order requiring such person to comply with such condition or limitation or shall bring a civil action in accordance with subsection (b hority in paragraph (3) (2) 5'1 Admini limits so win failur limits Admini day a: findin and en will e' to in enforce paragrs enforce person (A) 11m (B) sec (3) ?he the Adm section in vioh any of this AC1 person I bring I section. A cc sent imm violaticr which an under PI corporati any appro subsectio shall not had an 0F the allegt (A) A persor nature compli viola: mainte Admini viola: sericJ comply 90 STAT. 2020 I?ablieatioa in Federal ltegialei. Documents. Publication in Federal Register. l5 2605 sags. PUBLIC LAW II. I976 (5) The Administrator iuav. upon application. to. he. the require- tneuts of subsections and inapplicable with respect to the manufacturing or pnressiug of auj chemical auledamte. (A) which exists temporarily as a new I of a u-mical react ion in the manufac- turing ru- ol a mixture or another chemical substance. amt (It) to which there is no. and will not be. human or environmental exposure. (ti) Immediately upon receipt an application under paragraph (I) or (5 the. Ailministiator shall publish in the. Federal llegistcr notice 0 I Iccript oI such application. The Administrator shall 'ive inleiested peiwms an opportunity to comment upon any such applica~ tiou aml shall. ithin If: dajs its receipt. either approve or deny the application. The Administrator shall publish in the Federal Itegistcr notice at the appnn at or denial at such an application. purposes of this section, the terms ?manufac- ture" and ?process" mean manufacturing or priming tor munuei-cial put-lanes. SEC. A. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES. Sui-oer. or the Administrator ?nds that there is a reasonable basis to conclude that the pres-ceasing. dis- tribution in cmumen-e. use, or ilislamal of a chemical substance or mixture. or, that. anyI cmubination of such activities. presents or will present an mueasouable risk of injury to health or the environment. the Administrator shall he rule apply one or more of the following requirements to such sub-statue or mixture. to the extent. nmary to protect adequately against. such risli using the. least burdenmmc requirements: (I) relpiin-meut prohibitingthe manufacturing,prraw- ing. or distribution in commerce of such substance or mixture, or (It) limiting the amount of such substance or mixture. which may . be. manufactured. [It'lu'r-swul. or distributml in muuncme. (2) (A) pmhihiting the manufacture. pita-easing. or distribu- tion in eonuuen-e of such suln?lanl'e or mixture for a particular use or (ii) a particular use in a concentration in excess of a level speci?ed by the Administrator in the rule imjmsiug the requirement, or (it) limiting the amount. of such substance or mixture which may be manufactured, pml, or distributed in commerce for a particular use or (ii) I particular use. in a mneentaation in caress of a level speci?ed by the Administrator in the rule imposing the requirement. (.1 A mpiiremeut that such substanne or miature or any artie containing such substance or mixture be marked with or accompanied by clear and adequate. warnings and instructions with reslu-ct to its use, distribution in commerce, or disposal or with respect to any combination of such activities. The Inrm and mutcnl of such warnings and inst ructious shall be by the Administrator. (4) requirement that manufacturers and at such substance or mixture make and retain records of the processes used to manufacture or phone!? such substance or mixture and monitor or conduct tests which are reasonable and necessary to assure compliance with the requirements of any rule underthis subseetion. I A it?! ?11? PUBLIC LAW 94469?00. ll. I976 (ti) A requirement manner or "ritual 0 mixture. (EMA) requirement prohibitingor otherwise regulating any manner or method of dialer-sat of such substance or mirlurc. or of any article. containing such substance. or mixture, by its manu- facturer or processor or by any other person who uses. or disposes of, it. Ior counucreial purpmes. (It) A requirement under subpara raph (A) may not. require any verso" to take any action whici would be. in violation of any an or requircnmitiot', or in etTeet for. a State or political aulalivisiou, and shall require. each person subject to it to out?t: each State and political sulalieisiou in hirh a required disposal mav occurol such dislunal. (7) A requin-meut. diiecting manufacturers or processors of such substance or miatme (A) to give notice of such unreasonable. rislt of injury to distributors in commerce of such substance or mixture and, to the estent reasonably ascertainablc. to other per- sons in lawsession of such substance or miature or earmsed to such substance or iuistme, (It) to give public not ice of such risk of injury, and (C) to replace or repurchase such substance or nnatum as elected by tbe person to ahich the requirement is directed. iequin-iuent (or combination of requirements) imposed under this subsection may be limited in application to speci?ed geographic. prohibiting or otherwise regulating any 'commercial use of such aubstame or QUALITY (Tum..?lf the Administrator has a reamnalde basis to conclude that a particular manufacturer or is manu? facturing or liming a chemical substance or mixture in a manner which unintentionallv can? the chemical substance or miature to present. or which will cause it to present. an unreasonable. risk of Injury to health or the environment? (I) the Administlatnr may hy order require such manufac- turer or procesmr to submit a desrripl ion of the relevant quality control procedulrs followed in the manufacturing or 0! such chemical substance or mixture; amt (2) itthe Administratordctenuincs? (A) that such quality control procedures are inadequate to prevent the chemical substance or mixture from presenting auch risk of injury. the Administrator may order the manu- facturer or to revise such quality control procedures to the extent nmssary to remedy such inadequacy; or (II) that the use of such quality control procedures has resulted in the distribution in conunerce ol' chemical substances or mixtures which present an unreasonable risk of injury to health or the environment, the Administrator may order the manufacturer or to give notice such rislr to processors or distributors in mouerce of any such sub- stance or mixture, or to both. and. to the extent reasonably ascertainahte. to an]I other penaon in gnaw-?ion of or eslmci to anr such substance, (ii) to ice public notice. of such risk. I?d to provide such rep acement or repurchaw of any such substance or miature as is necessaiy to adequate!) pro- tect. health or the environment. A detenuinal ion under subparagraph (A) or (II) of paragraph shall he made on the re?trll alter op ui?unitv for hearing in accoril~ Inca with section of title States t'ode. Any manufacturer 90 STAT. 202i Hearing. i run or otherwise known to the applicant In the map area Group ll storm water discharges. as defined in I 122.2titblr3l. are exempt from the requirements of paragraph (fl (7) of this section. (Bl A brief description of the nature of the businen. (9) For Group ll storm water dis- chargers (as defined In 123.26th only. a brief narrative description of: ill The drainage area. Including an estimate of the sine and nature of the area; (Ill The receiving water: and Any treatment applied to the dischane. igi Application requirements for ex- isting manufacturing. commercial. mining. and siloicalfarol Existing manufacturing. commercial. mining. and slivicultural dischargers applying for NPDES permits ahaJl pro- vide the following information to the Director. using application forms pro vided by the Director: ill Oat/ail location. The latitude and longitude to the nearest lb sec- onrh and the name of the receiving water. (2) Line draroisp. A line drawing of the water flow through the facility with a water balance. showing oper~ ,ations contributing wastewster to the *offluent and treatment units. Similar procenes, operations. or production areas may be indicated as a single unit. labeled to correspond to the more de- tailed identification under paragraph of this section. The water bal- ance must show approximate average flows at intake and discharge points and between units. Including treat- ment units if a water balance cannot be determined (for example. for cer- tain mining activities). the applicant may provide Instead a pictorial de- scription oi the nature and amount of any sources of water and any collec- tion and treatment measures. (3) Average limos and treatment. A narrative identification of each type of pm. operation. or production area which contributes wastewater to the effluent for each outfall. Including proceu wastewalaer. cooling water. and stormwater runoff: the average flow which each process contributes: and a description of the treatment the wash-water receives. including the ultl- dun-r.? mate disposal of any solid or ?uid wastes other than by discharge. Proc- esses. operations. or production areas may be described in general terms (for example. "dye-making reactor". ?dis- tillation tower"i. For a privately owned treatment works. this Informa- tion shall include the Identity of each user of the treatment works. til Intermittent ?ours. if any of the discharges described In paragraph (gm of this section are Intermittent or seasonal. a description of the fre- quency. duration and flow rate of each discharge occurrence (except for stormwater runoff. spillage or leaks). (5) Mos-imam production. it an ef- ?uent guideline promulgated under section 304 of CWA applies to the ap- plicant and Is expressed in terms of production (or other measure of oper- ation). a reasonable measure of the ap- plicant's actual production reported In the units used In the applicable ef?u- ent guideline. The reported measure must re?ect the actual production of the facility as required by tumors). (0) improvements. If the applicant Is subject to any present requirements or compliance schedules for construction. upgrading or operation of waste treat- ment equipment. an identification of the abatement requirement. a descrip- tion of the abatement project. and a listing of the required and projected final compliance dates. t'ii Eminent characteristics. Informa- tion on the discharge of pollutants speci?ed in paragraph. When "quantitative data" for a pollutant are required. the applicant must collect a sample of effluent and analyse It for the pollutant in aomrdanoe with ana- lytical methods approved under 40 CPR Part us. When no analytical method is approved the applicant may use any suitable method but must pro- vide a description of the method. When an applicant has two or more outfalis with substantially Identical ef- fluents. the Director may allow the are plicant to test only one outfall and report that the quantitative data also apply to the substantially Identical outfalis. The requirements In para- graphs (gii?ii (Ill) and (iv) of this sec- tion that an applicant must provide quantitative data for certain pollut- 66 ants known or believed to be present do not apply to pollutants present in a dimham solely as the run". of their presence in intake water: however. an applicant must report such pollutants as present. Grab samples must be used for pH. temperature. cyanide. total phenols. residual chlorine. oil and grease. and fecal collforrn. For all other pollutants. 24-hour composite samples must be med. However. a min- imum of one grab sample may be taken for ef?uents from holding ponds or other Impoundments with a retention period greater than hours. and a minimum of me to four ti) grab samples may be taken for storm water discharges depending on the duration of the discharge. One grab sample shall be taken in the first hour (or less) of discharge with one additional grab sample taken in each succeeding hour of discharge up to a minimum of four grab sampla for dis- charges four or more hours. in addition. the Director may waive com- posite sampling for any outfall for which the applicant demomtrates that the use of an automatic sampler is in- feasible and that the minimum of four (1) grab samples will be a representa- tive sample of the effluent being dis- charged. An applicant Is expected to "know or have reason to believe" that a pollutant ls present in an ef?uent based on an evaluation of the expected use. production. or storage of the pol- lutant. or on any previous analyses for the pollutant. (For example. any pesti- cide manufactured by a facility may be expected to be present In contami- nated storm water runoff from the fa? cility.) (INA) Every applicant must report quantitative data for every outfall for the following pollutants: Bioehemial Oxygen Demand Chemical Oxygen Demand Total Organic carbon Total Suspended il-ollth Ammonia (as H) Temperature (both winter and summer pl-l (B) The Director may waive the re- porting requlrements for individual point sources or for a particular indus- try category for one or more of the pollutants listed In paragraph igii'ililiihl of this section If the appli- rm: cant h- delnoratrated that such a waiver appropriate beat-e prior-ras- tion adequate to support hmanoe of a permit can be obtained with Ian strin- gent requirements. iill Inch applicant with props-ea In one or more primary loot-try category tsee Appendix A to Part In) contrib- uting to a dischars'e mint report quan- titative data for the following pollut- ants in each outfall containing proceai AppendixDofthispart for theappii- cant's category or categories unle- the applicant qualifies as a small blaring under paragraph (girl) of section. Table ll of Appendix Iutants in each fraction. The fraction result from the ample preparation re- quired by the analytical pmdure which mes gu chromatography/roan spectrometry. A determination that an applicant falls within a particqu in- dustrial category for the purposes of selecting fraction for testing is not conclusive as to the applicant's inclu- sion in that category for any other ml?ee?otcalluydiofihis section] (B) The pollutants lhtod in Table metals. cyanide. and total phenohi. Each applicant Int-t indicate whether it knows or has reason to be- lieve that any of the pollutants in TabieWoprpendlaDioertalnoon? ventionsi and nonconventlonai pollut- ants) dhcharged from each outfall. if an applicable effhsent limitation guideline either directly limits the pol- lutant or. by its expre- lerun. Indi- rectly limits the pollutant through Iimitaiiorl on an indicator. the appli- cant Int-t report quantitative data. every pollutant discharged which is not so limited in an effluent limita- tiom guideline. the applicant mill. either report quantitative data or briefly dun-Ibo the res-or- lhe pollut- ant is expected to be discharged. (Bi Each awliunt must Indicate whether It knows or has reason to be- lieve that any of the pollutants lists-d In Table ll or Table Ill of Appendix (the toxic pollutants and total phen- ols) for which quantitative data are 9:21.11 not otherwise required under para- graph (gli?llili) of this section. is dis- charged from each outfall. For every pollutant expected to be discharged In concentrations of [0 or greater the applicant must report quantitative data. For acroleln. acrylonltrile. 2.4 dinltrophenol. and 2-methyl-4.6 dini- trophenol. where any of these four pollutants are expected to be dis- charged In concentrations of 100 or greater the applicant must report quantitative data. For every pollutant expected to be discharged In concen- trations lea than 10 ppb. or In the case of acroleln. acrylonltrile. 2.4 dini- trophenol. and 1-methyl-4i.d dinltro- phenol. In concentrations less than 100 ppb. the applicant must either submit quantitative data or brie?y describe the reasons the pollutant is expected to be discharged. An applicant qualify- ing as a small business under para- graph (git!) of this section is not re- quired to analyse for pollutants listed In Table ll of Appendix (the organic toxic pollutants). (Iv) Each applicant l'l'ltll indicate whether It knows or has reason to be- lieve that any of the pollutants in Table of Appendix of this part (certain hazardous substances and as- bestos) are discharged from each cut fall. For every pollutant expected to be the applicant must brie?y describe the reason the pollub ant is expected to be discharsed. and report any quantitative data It has for any pollutant. Each applicant mint report quali- tative data. generated using a screen- ing procedure not calibrated with ana- lytical for 2.3.7.0-tetrachlor- odlbenao-p?dioxin (TCDD) If It: (A) Uses or manufactures Its-trien- Iorophenosy acetic acid 1- propanoic acid (Bilvex. 2.4.5.3113): 142.4.l-tr1ch- iorophenoxy) ethyl. pionate (Erhonl: 0.0?dlmethyl 0- (2.i.ti-trichlorophenyl) phosphoroth- ioate (Ronnel); 2.4.0-trichlorophenol or hexachlorophene or (B) Knows or has reason to believe that TCDD Is or may be present in an ef?uent. Small business exemption. An ap- plirant. which qualifies as a small busi- Under one of the following crite- OI. I (7-1-06 Edition) ria is exempt from the requirements in paragraph {gii'llilixAl or of this section to submit quantitative data for the pollutants listed In Table ll of Appendix of this part ithe or- ganic toxic pollutants): (I) For coal mines. a probable total annual production of less than 100.000 tons per year. (ii) For all other applicants. gron total annual sales averaging less than "00,000 per year (in second quarter loco dollars). (I) Used or manufactured torics. A listing or any toxic pollutant which the applicant currently uses or manu- factures as an intermediate or final product or byproduct. The Director may waive or modify this requirement for any if the applicant dem- onstrates that It would be unduly bur- densome to Identify each toxic pollut- ant and the Director has adequate In- formation to issue the permit. (10) Storm mater point source as- it) An applicant that quali- charser under ?1120(an Ia exempt from the requirements of mm (fli'll and is) of this section. unle- the Director requests such informa- tIon. (ii) For the of paragraph (all!) of this section. storm water point may estimate the aver- age flow of their discharse and must Indicate the rainfall event and the method of estimation that the esti- mate is based on. (ill) The Director may require addi- tional information under paragraph (gxll) of this section. and may re- quest any Group ll storm water dis chargers to comply with paragraph of this section. (it) tonic-its tests. An identification of any biologicnl toxicity tests which the applicant knows or has reason to believe have been made within the last 3 years on any of the applicant's dischmes or on a receiv- Ing water in relation to a discharge. analyses. If a contract laboratory or consulting firm per- formed any of the analyses required by paragraph (gli'l) of this section. the identity of each laboratory or firm and the analyses performed. PrehIiIInAg-rey l. . lc?jrjg" on. (Is?isuman tlon to the information reported on the application form. ImtIcants dhail provide to the Director. at his or her request. such other information as the Director may reasonably require to the discharges of the facility and to determine whether to issue an NPDM permit. The additional infor- mation may Include additional quanti- tative data and bioamya to sue- the relative toaicity of discharges to aquatic life and requirements to deter- mine the cat-e of the toxicity. (hl? application requirements a? new and airline concentrated animal feedino (nitration; and Mastic animal production facilities. New and existing concentrated animal feedir? oper- ations (defined In [11123) and con- centrated aquatic animal production facilities (defined in I 123.24) shall provide the following information to the mrector. wing the application form provided by the Director. ill hr concentrated animal operation (?The typeandnumberofanm in open confinement and housed under roof. (II) The nurnber of acres med for confinement feeding. (Ill) The drain bash for the muff diversion and control system. if one exhts. Including the number of acres of contributing drainage. the storage capacity. and the design mety factor. (2) For concentrated lunatic animal production facilities: (I) The maximum daily and average flow from each outfall. (II) The number of pooch. raoewaya. and similar structures. (Ill) The name of the receiving water and the source of Intake water. (Iv) For each species at aquatic ani- mals. the total yearly and maximum harvestable weight. The calendar month of maxi- mum feeding and the total man of food fed during that month. (I) Application requirements new and existing POTWs. [Reserved] (ll Application requirements for new sources and new dischoroers. [He- served! (In) Special provisions for applica- tions from new sources. The owner or operator of any facility which may 121.21 and which i located in a State with- out an approved program mint comply with the provisions of this paras'araph. -. (rsu Before bcsinning any ondte immiion I defined in I 112.?. the owner or operator of any facility which may be a new source rout submit information to the Regional Adminhtratormthatheorshecan stance. The Regional may reque? any additional informa- tion needed todetermlne whether the facilitybanewsoloos. (if) The Rector?l Achainhtrator shall make an Initial determination whether the facility a new source within )0 of receiving all neces- nry information under paragraph (I) The Regional minivans dial] hue a public notice in amorti- ancewitbllitl00fthepewsouros under paragraph (up ty I a new ounce. the notice shall state that the mint comply with the environmental review re- mouncmuoseim. (i)Anymterestedperaonmaychni- BubpartEofParthwithmJiichy-s of ?nance of the public notice of the Initial determination. if all parties to the evidentiary hearing on the deter- mination agree. the Electoral Adminis- trator may defer the hearing until after a final permit decision In made. and cor-olidate the hearing on the de- termination with any hearing on the permit. if) Variance wants or non-m A til-charter which is not a publicly owned treatment works may request a variance from otherwbe ap- plicable effluent limitations under any of the following statutory or regula- tory provisiorl within the tlmva speci- fied in this Mb: randomentolly diners-at before. A request for a variance based on the presence of ?fundamentally different factors" from those on which the ef- fluent limitations guideline was based. 69 In. the remit by the totIl wutewIter flow. Effluent limitations Ind atInd. um Io cnlculIted me be further Id- Jueted under PIrt I25. Buprrt to mIke them more or lees stringent If to Item. publicly owned treItment warts. or by hand Ipplim- ohInIe the chIrIcter or treILIbil- Ity of the poilutInLIt being discharged to receiving wItern. This method me be Ilgebrxically expretmed In: Ex" 1' where II the permit ef?uent IlmltI- tion. the IImItItion derived by Ip- plying ef?uent guidelines to the totIl wutetrtreIm. In the wItrtewIter flow to be treIted Ind dlechIrted to _wItero of the United States. end 1' II the tow mtewIter flow. (bl PIrIcr-Iph (I) of this ~Iection does not Ipply to the extent thIt pro- :tltnulgIted effluent limitations [ulde- en: ti) Control mutation of poliui, IntI dIIc but not mun: or (2) Bpec Iy I different specific tech- nique for adjusting ef?uent limitI- tionI to Iccount for well Injection. IInd Ippiicetlon. or disposed Into PImrIph (I) of thlI Iection door not Ilter I diachIr-Ier'e obilntlon to meet my more stringent requiremente euthlinhed under 122.1]. 122.42. 122.43. Ind 122.?. I'll Itm. Apr. I. Im. II amended It "000. Hept. 20. I?ti levee-tion end R'eluwwneo, Ind terrain-tion If Penile lint! MevofH?Iinp?e-Heto StIte mun. lee I 121.23). (I) Moder: by modi?cation. Except II provided In of this section. I permit me be trInI- ferred by the permittee to I new owner or Openior only If the permit hoe been modified or revoked Ind re- turned (under [122.62tbi?ll. or I minor modlfIcItion trade (under to identify the new per- 94 0 CF. Oi. i (74-06 Edit-In) mlttee Ind incorponte each other re- quirements II me be necemIry under CWA. (bl Alfomotic from". AI In Ilter- nItIve to tun-fern under pIrIIrIph (I) of mu section. may permit me be IutornItchliy trInaferred to I new permittee If: (I) The current permittee notifies the Director It Just 30 one In Id- nnce of the provost-d tronsfer one In pIrIerph (our) of thin section: (1) The notice Includes I written ureement between the exlItlnI Ind new contIining I specific mm for trImfer of permit responsibil- ity. coverIee. Ind IiIbliity between them; Ind (3) The Director doe- not notify the ?tting permittee Ind the proposed new permittee of Me or her Intent to modify or revoke Ind reimue the permit. A modification under the rub- pIrIngph run It? be I minor modifi- cItIon under [122.03. if thiI notice not received. the trImfer in effective on the dIte speci?ed In the Irreement mentioned In pIrImph (bit!) of this section. lint! NM or "routine Ind If per-mite IIppiie-Ibie to When the Director receive- my In- formation (for exImpIe. inn-pect- the fIcIiity. receiveI IrtforroItlon Iubmit- ted by the permittee II required In the permit (Iee reoelree I re- run? for modification or revocItlon Ind rel-thrice under ?31.5. or con- clude I review of the permit file) he or Ihe me determine whether or not one or more of the cam Illied In pIrI- mphI iI) Ind lb) of thin Iection for modlfIcItion or revocation Ind reII- IuInce or both exist. if cIuIe exists, the Director InIy modify or revoke Ind relmue the permit rubiect to the IImItItlonI of to) of mu Iection. Ind me request In udeted IppiicItlon If my. When I pen-nit iI modified. only the condition subject to modification Ire reopened. If I permit II revoked Ind returned. the entire permit II reopened Ind subject to revision Ind the permit II releeued for I new term. Bee inure-x2). If cIune does not exist Eminent-IMAM under Iection or ?2213. the Di- rector not modify or revoke Ind reissue the permit. if I permit modifi- cItion IItIIfleo the after? In I for "minor modIfIcItiorl" the permit me be modified without I permit or public review. Otherwise. I on? permit must be prepIred Ind other procedures In PIrt I34 (or m- duru of In Ioproved ?ute pvoerum followed. (I) Comm mutilation. The fol-. lowing Ire for modification but[ not mutation Ind reImuInce of per- mitI except when the permittee re-- quest or Inca. (I) Alteration. There Ire Inter-II? Ind IubItIntiIl IiterItiorI or Iddi- tioru to the permitted fIciIIty or Ictle- i lty which outurred Ifter permit hu-I more which ley the application of permit oonditionl thIt Ire different or Ibeent In the existing permit. (2) immrton. The Director received new lnfomtlon. PermitI me be modified during their term for thin mine only If the not It the time of permit (other then reviled mulI-I tionI. guldInce. or tent methoch) Ind 5 would the imtmed the IpplicItlon of . different permit condition It the time of immune. For men eeneru per-i mite tl 122.38) thII cIuIe Include- Inyl InformItion thIt cumuiI-f tlve effectI on the environment Ire- unlocepthie. I (I) New re?li?m The or reguIItlonI on which the permit booed the been ehInIed by pro- mulgItlon of Intended mm or reguIItiom or by iudicIIi decision Ifter the permit lsued. PermltI run be modified durinI their terrm for come only II follows: (I) For promulgItlon of Intended ItIndIrth or when: (A) The permit condition roqueeted to be modified boned on I promul- nted ef?uent IIrnitItlon I'Uideline. EPA Ipproved or promng-Ited wIter quIIity ItIndIrdI, or the SecondIry 'heItment RegulItlom under PIrt 133:Ind (Bi EPA revised. withdrewn. or modified thIt portion of the regulI- In? tion or effluent midellne on which the permit condition bened. or Ipprored I BtIte action with ward to I wIter quIlity ItIndIrd on which the permit condition bIIed: Ind (C) A permittee requevtI modifier tion In IccordInce with I mt within ninety (90) due Ifter Menu. Roots- TII notice of the Ictlon on which the requevt iI bIIed. (II) For iudchII decision. I court of competent iuriIdietlon remanded Ind vtIyed EPA promulnted regulI- tlorw or effluent lImItItlon guidelineI. If the remmd Ind any concern thIt portion of the regulItlonI or guide- lines on which the permit condition bIIed Ind I request II filed by the permittee In IomrdInce with [121.5 1 within ninety (90) our of fudiciIl rernInd. For chIng-u upon motil- fied State certification of permItI, no I ?4-56th. Compliance relied-Ila. The Direc- tor determineI good cIttIe exIItI for modificntion of I compllInoe schedule, vuch II In Id of God. strike. flood. or IhortIg-e or other eventI Over which the permittee little or no control Ind for which there II no reIIonIny remedy. However. In no one run In NPDEB Ichedule be modified to extend beyond In IpplIchle CWA statutory deIdIine. Bee [121.0303 (minor modifica- tion) Ind mh tIitltl of thi- Iectlon InnovItlve technolo- (I) When the permittee flied I requeet for I vIriInce under CWA Iec- tion 30in). 301m). scum. 301m. 301th). or ll?I) or for "fundImentIi- ly different ?tion" within the time specified in 122.11 or I (0) Who) tax-ta. When required to Incorporate In IppIIchle toxic effluent mm or prohibition are I22.ttib)l. t7) Reopener. When required by the "lie-opener" condition In I permit. which Ire eIthIIshed In the permit under Iantibl (for CWA toxic ef- fluent IimltItlonI) or to CPR 401mm (pretreItment pron-Int). except thIt when I modifchtion cIIurIe established under 10 CPR ?01!de relates to the Incorporation In I permit of I 95 .- . - - u.s. tunusrny COOPERATIVE nonxn swuny II. Purpose The parties agree that use of a cooperative study to provide these data is the most efficient strategy for meeting EPA's responsibilities in light of the need for rapid data development and comprehensively organized allocation of limited laboratory capacity. Further, use of a cooperative agreement will ensure. that the sampling and analyses are conducted in a consistent manner with EPA-approved quality assurance/quality control measures . Collection of these data will assist EPA to fulfill its - regulatory responsibilities. Under the Clean Water Act (CWA), EPA is required to promulgate and update effluent limitations guidelines and standards and other water quality regulations, as well as to issue NPDES permits where states are not authorized to do so. Under the Toxic Substances Control Act (TSCA), EPA is authorized to regulate various activities which may present an unreasonable risk of injury to health or the environment as well as to establish other types of controls. In furtherance of these functions, the CWA and TSCA authorize EPA to gather information and require the submission of test, monitoring, and other types of data. While API and the participating companies do not necessarily ?t A agree that EPA has authority t5 demand all of the information provided in this cooperative skudy, Ail and the participating - 1' I.4 companies have agreed to cooperate with EPA in order to assist the Agency to evaluate dioxin generation at pulp and paper mills and to assure that the needed information is collected in an efficient, orderly way. (As used in this Agreement, "participating companies" refers to those companies which are signatories to this Agreement.) General Project Organization and ReSponsibilities 1. API Responsibilities 1.1 API has identified, on Attachment 4, all mills in the United States which are known to operate chemical wood pulping mills bleaching with chlorine or chlorine derivatives. 1.2 API shall use its best efforts to secure the participation in this Agreement of all companies which own or partially own any of the mills listed in Attachment 4, regardless of whether those companies are members of API or NCASI. 2. Participating Companies' Responsibilities 2.1 Participating companies will provide the bleach plant information described in Attachment 1 and the wastewater treatment and sludge management information described in Attachment 3 to NCASI for each mill identified in Attachment 4 in order for NCASI to make timely submissions of aggregated mill data according to the schedule set forth in Paragraph 3, below. This provision does not require the generation of any new analytical data but rather is intended to be based on available information or estimates. 2.2 Participating companies, when requested by NCASI, Ishall collect effluent, bleached pulp, and wastewater treatment plant sludge samples, following the sampling program described in Attachment 2, for each mill listed on Attachment 4, and shall submit these samples to NCASI no later than the date established by NCASI as necessary to meet its data analysis and reporting commitments in Paragraph 3, below. Prior to initiation of the sampling program at each mill, the person responsible for the sampling program shall assure that applicable bleach plant monitoring and reporting systems are operational and in good working order so that the data requested in Attachment 2, Item 5 can be obtained as accurately and completely as possible within the context of existing monitoring systems at the mill. The person responsible for the sampling program shall also assure that, during the sampling program, data and information are collected in accordance with Attachment 2 and with the sampling protocol which is to be developed by NCASI and will be subject to EPA review upon request. 2.3 Each participating company shall, not later than 30 days after the Agreement takes effect, submit to NCASI the results of any analyses for chlorinated dioxins or chlorinated furans which that company has obtained for samples of wastewaters (treated and untreated), wastewater treatment sludges, bleached or partially bleached pulps, other process raw materials or chemical additives used in the process of manufacturing bleached pulp, treated process (intake) waters, and any fish or environmental media, which have been obtained from any mill identified in Attachment 4 that is owned, partially owned, or operated by that company. 2.4 Participating companies shall provide EPA and state environmental agency representatives with access to any mill listed in Attachment 4 in order to observe the sampling being conducted pursuant to Paragraph 2.2, above. 2.5 Participating companies shall, at the time any data are submitted to NCASI, submit to NCASI in writing any claim of confidentiality which they intend to make for such data. Such submission shall also designate the company representative to be contacted about any matters concerning the confidentiality claim. Participating companies agree not to assert any claim of confidentiality for analytical data on treated or untreated wastewater or wastewater treatment sludge. Participating companies may also choose to send information directly to EPA rather than through NCASI for reasons of confidentiality, or they may seek to enter into separate confidentiality agreements with EPA, to the extent permitted by 40 C.F.R. Part 2, to supplement this Agreement. 2.6 Whenever any mill submits information to NCASI or EPA pursuant to this Agreement, that submittal shall be treated as information submitted under 40 C.E.R. ?122.22(b) and shall be accompanied by a written certification to EPA in accordance with 40 C.F.R. ?122.22. 3. NCASI Responsibilities 3.1 To insure that analytical testing will not be influenced in any way by sample origin and to protect possible confidential business information, samples submitted to analytical laboratories and information reported to EPA by NCASI will be identified by code numbers. No later than 15 days after the Agreement takes effect, NCASI shall assign unique code numbers to the mills identified in Attachment 4. Data shall be reported by NCASI to EPA using the mill code numbers, but NCASI shall provide EPA with a list of the mill code numbers and the identity and location of the mills which they represent within 15 days after the Agreement takes effect. 3.2 NCASI shall compile, review for completeness, and submit to EPA the information described in Paragraphs 1, 2, and 8 of Attachment 1 and Paragraph 1 of Attachment 3 no later than 60 days after the Agreement takes effect. (EPA recognizes that, due to this tight schedule, data for a few mills might still be unclear and unverified by this deadline. These data will be submitted as soon thereafter as feasible, but not later than 120 days after the Agreement takes effect. . i 3.3 NCASI shall compile, review for completeness, and submit to EPA the information described in Paragraphs 3-7 of Attachment 1 no later than 120 days after the Agreement takes'. effect. (EPA recognizes that, for reasons of confidentiality) some mills may choose to submit this information directly to EPA.) NCASI shall compile, review for completeness, and submit to EPA the information described in Paragraph 2 of Attachment 3 no.1ater than 90 days after the Agreement takes effect. 3.4 Within 30 days after the Agreement takes effect, NCASI shall submit to EPA a description of a more intensive study of a group of approximately 25-30 mills, to be conducted by NCASI researchers. This submittal shall also include a list of the mills to be examined as part of the NCASI study (the "Intensive Study Group"). Within twenty-one (21) days of receipt of study plans, EPA shall submit comments to NCASI on the plan and on the selection of mills to be included in the Intensive Study Group. NCASI shall consider those comments and, if appropriate, incorporate them into the final study plan. NCASI shall provide EPA with a copy of the final study plan within twenty-one (21) days of receipt of EPA's comments. 3.5 The information collected by NCASI at mills in the Intensive Study Group will go beyond_that described in Attachment 1" ?0 2 to this Agreement: however, all of the samples and operating information described in Attachment 2 shall be collected by NCASI at those mills and shall be reported to EPA in the same manner as all of the other mills listed on Attachment 4, as described in Paragraphs 3.6 and 3.7. The Parties anticipate, however, that, due to the limited number of experienced research teams available and the greater number of samples to be taken at mills in the Intensive Study Group, collection of samples from mills in the Intensive Study Group will not proceed as rapidly as at the remainder of the mills listed in Attachment 4. EPA has provided, in Attachment 5, a list of mills for priority sampling and analysis. To the extent that any of those mills also are included in the Intensive Study Group, EPA and NCASI will meet to resolve any differences concerning the priority in which mills should be sampled. NCASI will also, subject to EPA concurrence, prioritize the mills not on Attachment 5 or in the Intensive Study Group, which will collect their own samples, to be analyzed after those from mills listed in Attachment 5. That priority list shall be designed to assure, to the extent possible, that a range of mills with high, medium, and low usage of chlorine or chlorine derivatives are analyzed early on. 3.6 NCASI shall follow the protocols established in the Five Mill Study for the collection of the 5-day composite samples collected pursuant to Paragraph 2.2., with sample sizes being adjusted to match the analytical protocols. Pulp and sludge samples shall be processed dried, homogenized, and split) prior to being submitted for analysis, using the procedures in Attachment 7. NCASI shall archive at least two (2) aliquots of each composite pulp and wastewater sludge sample for a period of one year for possible future analysis. NCASI shall submit those samples to analytical laboratories according to a priority to be established in writing by agreement between EPA and NCASI. Beginning 60 days after the Agreement takes effect, such samples shall be submitted to analytical laboratories at an average rate of not less than 35 per week. Samples shall be prepared and analyzed for 2378-TCDD and 2378-TCDF in strict accordance with the analytical protocols specified in Attachment 1 of the quality assurance project plan for the U.S. EPA/Paper Industry Cooperative Dioxin Screening Study (copy attached}, or using an analytical protocol acceptable to all parties which has been demonstrated to meet the desired sensitivity and objectives. a. Analytical objectives The analytical objectives for detection levels of 2378-TCDD and 2378-TCDF for these analyses are as follows: 237B-TCDD Bleached Pulp and Wastewater Sludge 1 Process Wastewater Effluents 0.01 0.01 10 a0 EPA recognizes that it may not be possible to achieve the above detection levels for all samples. NCASI shall establish, in connection with the affected mills, a sampling schedule to assure that samples are available to be analyzed as quickly as laboratory capacity permits. As requested by EPA, to the extent possible pulp and wastewater samples gathered pursuant to Paragraph 2.2 will be analyzed and reported before sludge samples from those mills. NCASI will assure that, for each ten (10) samples of a given matrix, at least one field or laboratory duplicate sample and one matrix spiked sample will be analyzed. b. Interlaboratory comparisons At the outset of the study NCASI will send one duplicate sample each of effluent, sludge, and pulp from each of 9 mills to two laboratories for inter-laboratory comparison. In the event these inter-laboratory comparisons demonstrate that these laboratories do not provide comparable analytical results, the sampling and analysis schedule set forth in this Agreement shall be deferred until EPA and NCASI can resolve these discrepancies. c. Analysis for other and At EPA's request, NCASI shall have analyses of other and conducted,on samples of bleached pulp, treated wastewater effluent, and wastewater sludge from up to nine pulp and paper mills. The samples shall be analyzed for total 11 and 0CDD: and total and OCDF. Depending upon the results, NCASI shall have conducted at EPA's request isomer-specific analyses of selected and along with isomer-specific 2378-TCDD and 237B-TCDF and with individual quantitation of peaks which elute at the same retention time as the 2,3,7,3-substituted isomers using GC columns which are generally believed to be the most isomer-specific. It is understood by both parties that there are no analytical protocols for these determinations which have been validated in advance for pulp or for pulp and paper industry sludges or effluents. Furthermore, it is understood that the analytical detection limits for these determinations are likely to be higher than the target detection limits for 2378-TCDD and 2378-TCDF. Accordingly, specific criteria will not be established for the isomer-specific analyses. The parties agree that samples for the other and analyses from the nine mills shall not exceed 35 in number. 3.7 Laboratories shall be requested to provide to NCASI written analytical results, including worksheets and quality assurance/quality control data, for the samples described in Attachment 2 not later than thirty (30) days after receipt of the samples by the laboratory. Within fourteen (14) days of receipt of these data, NCASI shall review the data and determine whether the analytical testing results meet the identification and quantitation criteria set forth in Attachment 6. All analytical results from the sampling described in Attachment 2 12 which meet these criteria shall be forwarded to EPA, identified by mill code number and sample type, in a report to be submitted within 120 days after the Agreement takes effect and every 30 days thereafter (except that an interim report shall also be submitted on or about Hay 15, 1988). For each sample, these reports shall provide, in a format similar to that described in Attachment 6, the concentration of 237B-TCDD and 2378-TCDF, 9; the analytical detection limit for each compound, the percent recovery on the internal standard for each compound, and the monitored ion ratio for each compound. The same data shall be provided for duplicate, field blank, and spiked samples. If an analytical result does not meet the identification and quantitation criteria described in Attachment 6, NCASI may have the sample reanalyzed before any data are reported, but all analytical data received from the laboratories must be reported to EPA as described in Attachment 6. (EPA reserves the right to "audit" selected analytical results, in which case NCASI shall provide EPA with access to all laboratory documentation supporting the analyses.) The reports to EPA described in this paragraph shall also indicate the number of samples which have been transmitted to the analytical 1aboratory(ies) but for which results have not yet been received. Within thirty (30) days after submission of each data report described in this paragraph, NCASI shall submit to EPA the information described in Paragraph 5 of Attachment 2 for each mill for which analytical results for the associated samples were first provided in that data report. 13 3.8 NCASI shall bear the costs of storage, initial sample preparation, shipment to the analytical laboratory, and analysis for all samples collected pursuant to this Agreement. 3.9 Not later than 60 days after the Agreement takes effect NCASI shall briefly review the information submitted to it pursuant to Paragraph 2.3 of this Agreement and shall submit to EPA a list, coded by mill, of the type and amount of data, by media, received. That list shall be accompanied by an estimate of the time required for NCASI to review all of the data, compile it, and submit it to EPA along with appropriate qualifications as to the validity or significance of the data. (EPA does not agree in advance to concur with any qualifications NCASI may assign to the data.) EPA and NCASI will then agree on a reasonable deadline for the submission of this compiled and annotated data, but such deadline shall not be later than 150 days after the Agreement takes effect. 3.10 As soon as practicable after receipt of all analytical data for sampling performed at mills in the Intensive Study Group, but no later than 545 days after the Agreement takes effect, NCASI shall submit to EPA a comprehensive report setting forth the conclusions drawn from NCASI's work at mills in the Intensive Study Group and providing all supporting analytical data. It is presently anticipated that this report should be available within 365 days after the Agreement takes effect. (This Paragraph does not extend the deadlines for reporting any 14 of the information which EPA requested and which is described in Attachments 1-3 to this Agreement.) 3.11 On or before submitting any analytical data or other mill information to EPA pursuant to this Agreement, NCASI shall supply to EPA the mill certification required by Paragraph 2.6. NCASI agrees that, when submitting any data or other information to EPA, it will forward to EPA any claim of confidentiality which has been made by the company submitting such data to NCASI. 3.12 In addition to the work pursuant to this Agreement, NCASI has been conducting and will continue to conduct considerable research into the causes and the significance of dioxin formation in the bleaching process. NCASI agrees to submit to EPA, at a frequency not less than quarterly, beginning ninety days after the Agreement takes place and running until 15 months after that date, reports on the progress of this ongoing industry research program, which includes research on wastewater treatability, effects of process variables on dioxin generation, assessment of exposure to dioxin from pulp mill waste streams and products, and research on a pharmacokinetic risk assessment model for 2378-TCDD. These reports shall also describe progress in NCASI sampling and analysis for the mills in the Intensive Study Group. 15 4. EPA Responsibilities 4.1 Based on current information, EPA believes that the information described in this Agreement should be sufficient to characterize dioxin generation at the mills listed in Attachment 4. However, nothing in this Agreement shall be construed to limit in any way EPA's authority to require the submission of information not covered by this Agreement, to respond to conditions which EPA believes constitute an imminent and substantial endangerment to human health or the environment, or to take any action authorized under law, including permitting or enforcement under the Clean Water Act. 4.2 EPA shall consider the timely and complete implementation of this Agreement to constitute a sufficient and timely response by the participating companies to a request pursuant to Section 308 of the Clean Water Act, Section 4 of TSCA, or any other authorities for the same information on dioxin generation at the mills listed on Attachment 4. If any mill has not submitted the data subscribed in Paragraph 2.3 and Attachments 1-3 in a timely and complete manner, the Parties recognize that EPA shall use all available EPA authorities to collect the data. API, NCASI, and the participating companies waive any right they may have to challenge any Section 308 letter sent as a result of alleged failure to submit timely and complete data as described above on the grounds that EPA does not have authority under Section 308 to collect such data. EPA recognizes 16 that API, NCASI, and the participating companies waive the opportunity to challenge EPA's statutory authority to collect such data only with respect to any Section 308 letter arising out of an alleged failure to submit the data described in this Agreement in a timely and complete manner, and API. NCASI, and the participating companies have not waived their rights to challenge on any ground any Section 308 letter issued for any other data or in any other context. 4.3 EPA and any EPA contractor will treat all information for which a claim of confidentiality has been asserted in accordance with the procedures of 40 C.F.R. Part 2, Subpart B. The EPA contractor shall require any employee who may receive data obtained pursuant to this Agreement for which a claim of confidentiality has been asserted to sign a confidentiality agreement pursuant to 40 C.F.R. 5 Violation of such an agreement may result in the imposition of penalties referenced in 40 C.F.R. 5 2.211, including possible criminal prosecution for willful violation. 4.4 EPA will protect confidential business information in accordance with 40 C.F.R. Part 2, Subpart B. Although requested by API and NCASI to provide additional procedures beyond those in 40 C.F.R. Part 2 to protect business information determined by EPA to be confidential, EPA was unwilling to do so. 17 4.5 EPA shall choose the appropriate manner in which to release any information submitted to it pursuant to this Agreement after considering the confidentiality provisions of applicable federal environmental statutes and EPA regulations. 5. API, EPA, NCASI and the participating companies agree that: 5.1 References to collection of data from mills listed in Attachment 4 to this Agreement are not meant to require additional sampling and analysis at the mills which were the subject of the Five Mill Study, since samples similar to those described in this Agreement have already been collected and analyzed for those mills. Those mills are still required, however, to submit the information described in Paragraphs 2.1 and 2.3. 5.2 Wherever this Agreement requires notification of one of the Parties or submission of data to EPA, the notification or submission shall be addressed: For EPA, to: Mr. Thomas O'Farrell (WE-552) Chief, Consumer Products Branch Industrial Technology Division U.S. Environmental Protection Agency 401 Street, S.W. Washington, D.C. 20460 18 For API, to: Mr. Michael C. Farrar Vice President, Environmental and Health Program The American Paper Institute Suite 210 1250 Connecticut Avenue, N.w. Washington, D.C. 20036 For NCASI, to: Dr. Isaiah Gellman President National Council of the Paper Industry for Air and Stream Improvement 260 Madison Avenue New York, New York 10016 If it becomes necessary to replace one of these contact persons, the affected Party shall transmit to the other Parties notice of the replacement within five (5) days. 5.3 The Parties recognize that EPA or other federal agencies may desire additional information related to PCDD and PCDF formation in bleached pulp mills outside the scope of the information covered by this Agreement. The Parties recognize that it may be appropriate at some point in the future to enter into further cooperative efforts in addition to this Agreement to address those other information needs or to reflect ongoing research. 5.4 The Parties anticipate that it may be necessary to make minor modifications to the technical requirements and 19 deadlines contained in this Agreement. Such minor modifications can be made by unanimous written consent of the EPA, API, and NCASI representatives listed is Paragraph 5.2 and shall be binding on all participating companies. 5.5 This Agreement shall become effective upon x-signature of all Parties to the Agreement and shall terminate 575 days after the Agreement takes effect, except that the provisions of Paragraphs 4.1 through 4.4, and the requirements in Paragraph 3.6 and Attachment 2 for retention of samples, shall remain in effect. The undersigned parties hereby consent to this Agreement. AMERICAN PAPER INSTITUTE, INC. By: Red Cavaney President NATIONAL COUNCIL OF THE PAPER INDUSTRY FOR AIR AND STREAM IMPROVEMENT, INC. By: Isaiah Gellman President 20 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY By: By: William A. Whittington Charles L. Elkins Director Director Office of Water Regulations and Office of Toxic Standards Substances Companies, as reflected on the next page, owning or operating ,chemical wood pulping mills bleaching with chlorine or chlorine ?derivatives: 21 The following company hereby agrees to participate in the foregoing US EPA/Paper Industry Cooperative Dioxin Study Company BY Date (Signature of Officer Authorized to bind company) (Signer's Typed Name) Signer's Title: Signer's Phone Number: 22 ATTACHMENT 1 AVAILABLE BLEACH PLANT INFORMATION The following information shall be provided for each bleach line and for each type of wood processed. If both hardwood and softwood pulps are processed on the same bleach line, separate data for each type of pulp shall be provided. This provision does not require the generation of any new analytical data but rather is intended to be based on available information or estimates. 1. Current bleach plant schematic diagram (process block flow diagram) showing stages (unit operations/processes) for each bleach line and indicating the major connections and routes of flow for raw materials, chemical additives, intermediates, products, and wastewaters. Typical chemical application rates and typical residual chlorine concentrations for each bleaching stage. The measurement methods for sodium hypochlorite and chlorine dioxide solution strength must be specified. All chemical application rates shall be expressed as pounds of the Specific chemical per air-dried ton of brownstock pulp lbs. Clz/ton, lbs. NaOCl/ton, lbs. Cloz/ton, etc.). Amount of unbleached pulp processed and bleached pulp produced in a typical operating day. Typical pressure, temperature, detention time, and pH for each stage of bleaching. Typical Kappa Number and Permanganate Number for brownstock pulp and for pulp at each stage of bleaching. Typical brightness (GB) of pulp at each stage of bleaching. Typical washing loss (lbs. Na SO4/ton) for brownstock pulp. 2 Identify any unique process, such as oxygen delignification, that precedes pulp bleaching with chlorine. ?um? . ?1 ATTACHMENT 2 EFFLUENT, SLUDGE, AND BLEACHED PULP SAMPLING PROTOCOL Five-day (5-day) composite samples of each of the following three materials shall be obtained at each mill: a. treated wastewater effluent prior to dilution with cooling water: b. combined dewatered wastewater sludge: and c. bleached pulp following the final stage of bleaching The 5-day composite samples shall be collected concurrently with individual daily composite samples. The 5-day and individual daily composite samples shall be made up of eight grab samples per day collected at approximately equally spaced time intervals. For mills which have wastewater treatment systems with retention times greater than five days, the individual daily and five-day wastewater composite samples shall be made up of at least three grab samples per day (one grab sample per eight-hour shift). The required minimum sample volume for effluents shall be in accordance with the applicable analytical protocols, and for sludge and pulp shall be one quart each. Following compositing, the individual daily composige samples shall be held, sealed, in the dark at 4 until disposition is determined, but not to exceed a period of one year. For plants with multiple bleach lines, discrete individual daily and 5-day composite samples of bleached pulp from each line shall be obtained. The 5 sampling days chosen shall be representative of pulp grades produced in a typical year. If both softwoods and hardwoods are bleached intermittently on the same line, sampling days shall be chosen to allow for vthe collection of discrete 5-day composite samples of both types of pulp. If primary and secondary wastewater sludges are disposed of in different fashions, then 5-day composite samples of each type of sludge must be collected. Cleaning requirements for the sampling devices shall be as specified in Attachment 4 of the quality assurance project plan for the Industry Cooperative Dioxin Screening Survey (copy attached). Sample and aliquot bottles shall be cleaned according to U.S. EPA specifications for extractable organics. 3" a" . Individual grab samples shall be obtained dedicated, precleaned, sampling devices and deposited ectly into the sample containers. 1. Samples shall be kept chilled to and out'of the light, from collection through shipment to the analytical laboratory. The 5-day composite samples shall be shipped from the mill to NCASI within twenty-four (24) hours after completion of the 5-day sampling period. The following information, for each day of the 5-day sampling period, shall be obtained, recorded, nd submitted to NCASI (or directly to EPA) for each mill. 1 a. Wastewater effluent flow rate (24-hour total flow in gallons): b. Estimated wastewater sludge generation rate (wet tons/day and dry tons/day): c. For each bleach line, type of wood processed, . brownstock pulp feed rate, and bleached pulp production rate (tons/day of air-dried pulp): d. For each bleach line, daily average chemical application rates of chlorine, chlorine dioxide, sodium hydroxide, sodium hypochlorite, hydrogen peroxide, and any other chemicals applied. All chemical application rates shall be expressed as pounds of the specific chemical per air-dried ton of brownstock pulp lbs. Clz/ton, lbs. NaOCl/ton, lbs. Cloz/ton.) e. Wastewater effluent total suspended solids (mg/l and lbs/day). f. Temperature and pH for each stage of bleaching, where routinely collected. 9. Kappa Number and Permanganate Number for brownstock pulp and for pulps at each stage of bleaching, where routinely collected. h. Brightness of pulp for each stage of bleaching, where routinely collected. The documentation supporting these submissions shall be retained by the mill for at least one year. . ATTACHMENT 3 WASTEWATER TREATMENT AND SLUDGE MANAGEMENT INFORMATION Each mill subject to this agreement shall provide to EPA, through NCASI, the following information. This provision does not require the generation of any new analytical data but rather is intended to be based on available information or estimates. 1. A schematic diagram of the existing sewerage system for the mill including major wastewater sewer lines, major wastewater treatment system components, and sludge handling and dewatering facilities. To the extent available, provide daily measurements of total suspended solids in the treated process wastewater effluent (prior to dilution with noncontact cooling waters) for the period October 1986 - September 1987. The concentration of total suSpended solids, daily flow rates, and daily mass discharges (lbs./day of total suspended solids) shall be provided. The estimated retention time in hours for the wastewater treatment system at a specified wastewater flow rate, typical of mill production experienced over the October 1986 - September 1987 period, shall also be provided. If the discharge is non-continuous, the mill shall provide a narrative description of typical process wastewater discharge practices. For the period October 1986 September 1987, an estimate of the amounts of wastewater sludges generated (tons/day, dry weight) at the mill. Also provide a description of the current sludge disposal practice at the mill and sludge disposal practices for the past ten years. Wildlife ?87: Gaining Momentum is the theme for an exciting year declared to commemorate the 100th anniversary of the first. ildlife sanctuary in Canada. It Manama at Last Mountain Lake in skatchewan on June 8, l887. The focus of Wildlife '87 is conservation of wildlife and its past. present and future. The Wild ?87 year began with cross-Canada Christmas Bird Counts in December 1986. launched by the Minister for itat. Environment Canada in Prince Edward Island. A full year of vigorous activities, that re?ect the goals of Wildlife ?87. is underway. Watch for newspaper and periodical features. including special Wildlife ?87 issues of Nexus. Interpretation Canada Journal and Nature Canada. Individual land owners. conservation groups and governments are setting aside tracts of land as Wildlife Heritage Reserves and are working together to manage wildlife habitat. Commemorative ceremonies at Last Mountain Lake in June serve to focus attention on the need for ongoing conservation efforts. For details of these and other special activities occuring this year. check the Wildlife '87 Calendar of events available from your local contact. WILDLIFE ?87 is 0 working together to focus attention on wildlife and habitat gt? The celebration is gaining momentum. People across Canada are joining in: naturalists. sportsmen. corporations. governments. businesses. educators and students. Everyone is encouraged to participate in this ?birthday" year. You can give a gift to wildlife by: 0 setting aside a garden corner. hedgerow. pond, marsh. lake. 160 acres, or block of land for wildlife planting a tree or shrub. or retaining a woodlot that provides food and shelter for wildlife 0 participating in local events and creating conservation programs in local areas 0 making tax deductible donations of funds and/or land to local. provincial or national conserva- tion groups, and/or the National Steering Committee (please designate donations to Wildlife ?87) 0 contributing written material to local media about Wildlife projects. Share information on activities in your area by sending news and comments to Wildlife '87 National Committee and your local contact. ATTACHMENT 4 PULP AND PAPER INDUSTRY: CHEMICAL WOOD PULPING MILLS USING CHLORINE-BASED BLEACHING API Members: Alabama River Pulp Claiborne, AL Appleton Papers, Inc. Roaring Springs, PA Boise Cascade Corp. Jackson, AL DeRidder, LA St. Helens, OR Rumford, ME Wallula, WA International Falls, MN Bowater Corp. Catawba, SC Calhoun, TN Brunswick Pulp/Paper Brunswick, GA Buckeye Cellulose (PEG) Perry, FL Oglethorpe, GA Champion International Corp. Lufkin, TX Courtland, AL Quinnesec, HI Cantonment, FL Houston, TX Canton, NC Chesapeake Corp. West Point, VA Consolidated Papers, Inc. Wisconsin Rapids, WI Container Corp. of America Brewton, AL Flambeau Paper Corp. Park Falls, WI Federal Paper Board Co. Augusta, GA Riegelwood, NC Finch, Pruyn Co., Inc. Glens Falls, NY Georgia-Pacific Corp. Bellingham, WA Crosset, AR Palatka, FL Woodland, ME Zachary, LA (Port Hudson, LA) Gilman Paper Co. St. Marys, GA Gulf States Paper Corp. Demopolis, AL Hammermill Papers (IP) Erie, PA Selma, AL International Paper Co. Bastrop, LA Georgetown, sc Jay, ME Mobile, AL Moss Point, MS Natchez, MS Pine Bluff, AR Texarkana, TX Ticonderoga, NY ITT-Rayonier, Inc. Fernandina Beach, FL Hoquiam, WA Jesup, GA Port Angeles, WA James River Corp. Berlin, NH Camas, WA Clatskanie, OR Green Bay, WI Old Town, NE St. Francesville, LA Butler, AL Leaf River Forest Products (Great Northern Nekoosa) New Augusta, MS Longview Fibre Co. Longview, WA Louisiana-Pacific Corp. Ketchikan, AK Samoa, CA Mead Corp. Chillicothe, OH Escanaba, MI Kingsport, TN Nekoosa Papers, Inc. (Great Northern Nekoosa) Ashdown, AR Nekoosa, WI Port Edwards, WI Penntech Papers, Inc. Johnsonburg, PA Pope Talbot, Inc. Halsey, OR Potlatch Corp. Cloquet, MN Lewiston, ID McGehee, AR P.H. Glatfelter Co. Spring Grove, PA Procter Gamble Co. Hehoopany, PA Scott Paper Co. Everett, WA Mobile, AL S.D. Warren (Scott Paper) Hinckley, ME Huskegon, MI Westbrook, ME Simpson Paper Co. Anderson, CA Fairhaven, CA Pasadena, TX Tacoma, WA St. Joe Paper Co. Port St. Joe, FL Stone Container Corp. Hissoula, MT Panama City, FL Snowflake, AZ Temple-Eastex, Inc. Evandale, TX Union Camp Corp. Eastover, SC Franklin, VA Westvaco Corp. Covington, VA Luke, MD Wickliffe, KY Weyerhaeuser Co. Cosmopolis, WA Everett, WA Longview, WA New Bern, NC Plymouth, NC WI Wilamette, Ind. Hawesville, KY Members: Alaska Pulp Corp. Sitka, AK Badger Paper Mills, Inc. Peshtigo, WI Kimberly-Clark Corp. Coosa Pines, AL Lincoln Pulp/Paper Lincoln, ME Wausau Paper Mills Co. Brokaw, WI Summa API Members Members TOTAL 38 Companies 43 Companies 99 Mills 4% 104 Mills ATTACHMENT 5 EPA LIST OF MILLS FOR PRIORITY SAMPLING Companx Alabama River Pulp Boise Cascade Corp. Boise Southern Boise Cascade Corp. Buckeye Cellulose (P a G) Champion Intl. Corp Consolidated Papers, Inc. Container Corp. of Amer. Federal Paperboard Co. Federal Paperboard Co. _Georgia-Pacific Corp. Georgia-Pacific Corp. Gulf States Paper Co. Hammermill Papers Group Hammermill Papers (PT) International Paper Co. International Paper Co. International Paper Co. International Paper Co. ITT Rayonier, Inc. James R. Dixie/Northern Leaf River Forest Prod. The Head Corp. Nekoosa Papers Inc. P0pe Talbot, Inc. S.D. Warren (Scott P) S.D. Warren (Scott P) Simpson Paper Co. Union Camp Corp. Weyerhaeuser Co. (PT) Location Claiborne Jackson DeRidder Rumford Oglethorpe Catonment Nisc. des Brewton Augusta Riegelwood Crossett Woodland Demopolis Selma Erie Natchez Moss Pt Bastrop Pine Bluff Jesup Butler New August Kingsport Nekoosa Halsey Muskegon Hinckley Anderson Franklin New Bern AL0025968 AL0002755 L30007927 GA0049336 FL0002526 WI0037991 AL0002682 GA0002801 NC0003298 AR0001210 M20001872 AL0002823 AL0003018 PA0000124 ?30000213 H50002674 LA0007561 AR0001970 GA0003620 AL0003301 H50031704 TN0001643 WI0003620 0R0001074 MI0001210 HE0021521 CA0004066 VA0004162 NC0003191 ATTACHMENT 6 IDENTIFICATION AND QUANTITATION OF 2378-TCDD AND 2378-TCDF The criteria for identification and quantitation of 2378-TCDD and 2378 TCDF are as follows: 2378-TCDD 2378-TCDF Ion Ratio 320/322 0.65-0.89 Ion Ratio 304/306 0.65-0.89 Recovery 40-120% 1 Recovery 4o-120% Internal Standard Internal Standard If an analytical result does not meet the criteria described in Attachment 6, NCASI will review the analytical data received from the contract laboratory to determine what corrective steps would be appropriate. If internal standard recoveries are below 20 percent, the analysis will be repeated. If, after two analyses, the internal standard percent recovery is not greater than 20 percent, both analyses of the sample shall be reported as PEQ (present, estimated quantitation) if the analyte was positively identified or PND (probably not detectable) with the estimated detection limit indicated in parentheses. The respective ion ratio and internal standard recovery for each analysis shall also be reported. All 2378-TCDD and 2378 TCDF analytical data generated by NCASI pursuant to this Agreement shall be reported to EPA in a format similar to the following: buxmaUny nnxmauny and and qu?e Iabon?xmy ID 2378 Ion Percent Report 2378 Ion Percent Report NUmber? Matrix Trix: Ratio Recovery Date TCDF Ratio Recovery Date waSUaater ATTACHMENT 7 NCASI SAMPLE HANDLING AND PROCESSING PROTOCOL SAFETY GUIDELINES The analyst should be familiar with the General Laboratory Safety Rules, the Laboratory Work Practice Guidelines and the location and proper use of all safety equipment throughout the building fire extinguishers, respirators, spill kits, etc.). The following Dioxin general lab procedures recommends the use of specific safety equipment during various phases of processing. Included is the use of fume hoods for solvents or the processing of samples with nuisance odors and dust masks to prevent the inhalation of particulate matter. GENERAL LAB PROCEDURES Under no circumstances should a sample be touched, stored or in any way come in contact with any materials other than those prescribed below and then only after they have been properly prepared. Aluminum foil or unpowdered latex gloves require no pretreatment but fresh foil or a new pair of gloves should be used for each situation. I. CLEANING PROCEDURES A. Solvent Cleaning All materials (except aluminum foil and latex gloves) which come in contact with the sample (restricted to glass, stainless steel and Teflon) shall be solvent cleaned. Only Teflon squeeze bottles are to be used. The following cleaning procedure will be followed: (1) Soap and tap water wash all items using Pierce RES-35 soap (20 mL RES-35 per liter of tap water). Rinse with tap water following by deionized water. (2) Methanol (Burdick and Jackson) rinse. (3) Acetone (Burdick and Jackson) rinse. (4) Methylene chloride (Burdick and Jackson) rinse. (5) Air dry. Used solvents should be stored in separate bottles marked "Used Methanol," "Used Acetone," and "Used Conduct solvent rinsing in a hood. B. Glove Box Cleaning Procedure The following cleaning procedure should be used prior to and between each sample when using the glove box for sample grinding or sample splitting: (1) Vacuum all interior surfaces of the glovebox. (2) Wipe down all inside surfaces with a wet sponge. (3) Dry the glove box using a squeegee. Use a sponge to remove excess 0 from floor of glove box. If necessary an electric blow er can be used to speed up the drying process. (4) The neoprene glove box sleeves will be vacuumed, wet wiped with a sponge and air dried. A clean pair of latex gloves will be placed over them prior to processing any sample. C. Cleaning of Drying Cabinets The drying cabinets should be cleaned between usage by vacuuming, wiping all interior surfaces with a wet sponge, and then should be left to air dry. The vent will be wiped clean with a wet sponge More frequent cleaning is required if the analyst observes accumulated dust or particulate between cleanings. D. Cleaning of Blender Motor The blender motor should be dismantled and cleaned or any time the blender is dismantled for maintenance. E. Laboratory Cleaning Every two weeks the analyst should observe the general cleanliness of the laboratory and look for accumulations of dust or particulate in the room. Where possible wipe surfaces with a wet sponge and maintain an uncluttered work area. II. RECORD KEEPING All processing of any dioxin samples should be described in the appropriate "Project Lab Book" in ink. The West Coast sample control number should be noted and should precede all other sample identification information (such as dates and sample codes). The processor must date and initial each entry corresponding to a processing step. SAMPLE HANDLING A fresh pair of unpowdered latex gloves should be used for each sample and should be discarded after use. Reasonable efforts should be taken to protect samples from the direct light. Thus the lights should be turned off in cabinets used for drying samples except when required for handling and inspection. A dust mask should be worn during any processing where the inhalation of particulate matter is possible during grinding of samples). Samples producing a nuisance odor should be handled with proper ventilation. IV. SAMPLE PROCESSING (DRYING AND GRINDING) The following is a general procedure for processing samples that require drying and grinding. All air drying of samples must be done in a drying cabinet. When air drying samples the hood should be turned on and the doors closed. During the evenings when the janitors are scheduled to come in or when activity in the room may increase particulate levels in the air, turn the hood off with the doors closed. Samples are placed in the cabinets beginning with the top shelf until all shelves are full. If samples dry at varying rates no additional samples will be added until the last sample is dry and the cabinet is cleared. The samples on each shelf are segregated by a physical barrier. A. Blanks An 8" 10" Gelman type A glass fiber filter sheet should be placed in the center of the samples placed in the cabinets for drying. The filter sheet should not be pre-treated. Place the filter sheet on a piece of aluminum foil, edges folded up and label the foil with the date and time exposed in the laboratory. Barriers should separate the blank from samples on the same shelf in a manner analogous to the way samples are segregated. At the conclusion of drying of all the samples in the cabinet, the blank should be folded so as to cover the exposed upper surface and should be wrapped in aluminum foil until it is blended. Just prior to blending, the blank filter should be torn into small pieces and placed in the blender. Blend as described in Section IV Part D. Wrap the entire blended blank filter do not split the blended filter) in aluminum foil and place the foil packet into an I-Chem bottle. Do not assign a sample code to the blank until it has been put into the I-Chem bottle. The blank sample code is the next number in sequence in the West Coast sample sequence log book. Record the blank preparation, cabinet number, glove box number, the dates exposed, blended and bottled, and sample code assigned in the appropriate Project Lab Book. Record the Project Lab Book page reference number in the NCASI West Coast Dioxin Sample Sequence Log Book. B. Sample Preparation Procedures (1) Pulp Remove the pulp from the sample jar and hand squeeze out as much water as possible, discarding the water. Break the sample into small pieces (about dime size), lay out on a stainless steel screen supported about 1 cm above a sheet of aluminum foil and place the sample in a drying cabinet. The size of the foil should at least equal the area of the screen to catch and fines that may fall through. Wooden dowels wrapped in fresh aluminum foil are used to support the screen over the foil. Save the sample bottle, leaving the cap off until the inside moisture evaporates, for NCASI sample archives. Label the foil with the West Coast control number and the time and date the sample was laid out in the drying cabinet. This information and the drying cabinet number should also be recorded in the appropriate Project Lab Book. Continue with drying procedures Section Iv, Part C.l. (2) Sludges Remove the sample from the jar and break into small pieces (about dime size), distribute uniformly on a stainless steel screen supported about 1 cm above a sheet of aluminum foil and place in a drying cabinet. The size of the foil should at least equal the area of the screen to catch any fines that may fall through. Wooden dowels wrapped in aluminum foil can be used to support the screen over the foil. Save the sample bottle, leaving cap off until inside moisture evaporates, for NCASI sample archives. Continue with drying procedures Section Iv, Part C.l. C. Drying Procedure On a daily basis, check to see if the sample is completely dry and if not turn the material and further break it up into smaller pieces to facilitate drying. When the sample is completely dry, fold aluminum foil over the sample to cover it while waiting to grind. .When screens are used transfer the sample to the aluminum foil base and wrap for grinding. Record the date and time the sample was wrapped up. If the dried sample is not ground immediately store the covered sample in the dry sample storage cabinet. Grind the dried sample following General Procedure Section IV, Part D. D. Grinding Samples - The grinding (or blending) of a dried sample should be conducted in the glove box. The working surface of the glove box should be covered or lined with aluminum foil. The door to the glove box room should be closed and traffic through the room minimized. The processes of air drying and blending will be separated by as many physical barriers as possible separated on different floors). (1) Blend the entire sample in a properly cleaned blender (see Section I). Be sure not to add too much sample into the blender at one time otherwise blending will not be uniform and the blender motor may overheat causing fragments of the blender to mix into the sample. To check for overheating press the bottom of the blender assembly with gloved hands. If the assembly feels warm discontinue grinding until cool. Place the blended sample on a sheet of aluminum foil in the glove box. (2) Thoroughly mix the blended sample, using gloved hands or a stainless steel spoon, by turning the entire sample at least three times, then form into a conical pile. Carefully flatten the conical pile to a uniform thickness and diameter (as wide as spatially possible) by pressing down the apex. Divide the flattened mass into four equal quarters. Refer to ASTM "Standard Methods for Reducing Field Samples of Agregate to Testing Size.?I (3) An oven dried solids determination is required. Subsample each quarter and place on a small piece of foil to be transferred to a pre-tared crucible. Refer to standard Methods 209A pg. 93-95, of 16th (1985) edition. (4) Combine the opposing wedges into separate I-Chem jars two opposite wedges per jar). If more than two containers are required successively mix and quarter the opposing wedges until the sample aliquot is reduced to the size needed. (5) Label the jars with the sample code. The jar for NCASI archives should also have an added to the West Coast control number. When possible re-use original sample bottle for archives. V. SAMPLE STORAGE All samples other than processed blanks are refrigerated (4 C). ATTACHMQELQ COMPARISON OF ALTERNATIVE METHODS FOR GATHERING ADDITIONAL DIDXIN DATA METHODS FOR GATHERING ADDITIONAL DIOXIN DATA Two options?are avaiiabie: 308 letters to the 90 bieached kraft pulp (1 under CHA authority: (2) a cooperative agreement between EPA and Cooperative agreement with Draft study pian for cooperative agreement inciudes: a) b) sampiing/anajyses of effluents. puips. and sludges. process information. and avaiiabie dioxin anaiyses from 90 hieached kraft puip and approximateiy 15 additionai that use chiorine: detaiied information from 25 such as industry-generated research on dioxin formation and hieaching process modifications. wasteuater exposure studies. and dioxin Advantages n) b) C) EPA get more information than covered by ?308 authority (such as puip data) faster; industry uii1 fund work including additionai anaiyses. interiaboratory comparisons. and anaiyses for totai homoiogues; agreement does not iimit EPA's authority under agree not to litigate any ?3na 1eiters sent on the grounds that EPA cannot coiiect puip data under ?308; Disadvantages a) C) agreement is nonenforceabie: however. EPA may use its ?308 and TSCA authority (1) to obtain data from any which faiis to carry out the agreement in a timeiy manner and (2) to request other infonmation not Specified in the agreement from any if any firms faii to comply, there u0u1d be an added time delay rather than immediate enforcement; agreement may have the appearance of EPA/industry coiiusion; however. any agreement he pubiiciy noticed to avoid this; 0 Fact Sheet U.S. EPA/Paper Industry Cooperative Dioxin Study - Tier 1 . February 4, 1988 BACKGROUND Re5ults from the National Dioxin Study indicate that 2.3.7.8- tetrachlorodibenzo-p-dioxin (2378-TCDD) was detected in fish and river sediment samples collected from some pulp and paper mills located in various parts of the country. In June, 1956, the U.S. EPA Office of Hater (0H) entered into an agreement with the U.S. paper industry to study dioxin discharges at five bleached kraft pulp mills. Results of the U.S. EPA/Paper Industry Cooperative Dioxin 5-Mill Screening Study indicate that dioxin was detected in five of five wastewater sludges (3.3 - 180 parts per trillion or ppt), three of five treated effluents (not detected or ND - 0.12 ppt), and seven of nine bleached pulps (ND - 51 ppt). A report sunnmrizing the findings from the five-mill study should be available by late February, 1988. EPA's 0H and Office of Toxic Substances (0T5), the U.S. Consumer Product Safety Commission (CPSC), and the U.S. Food and Drug Administration (FDA) developed a collective interagency list of data needs to characterize fully the levels and potential public health impacts of dioxin generated during the pulp and papermaking process. The data needs listed were: - characteristic levels of dioxin and furan in the pulp, effluent, and sludge at all 105 mills that bleach chemical wood pulp with chlorine or chlorine derivatives - detailed process schematics, operating parameters, waste treatment methods, and sludge disposal practices at the 105 mills - assessment of potential migration of dioxin out of paper products - estimates of potential dioxin exposure routes to workers and consumers The U.S. EPA considered two alternatives for collecting the data from the 105 facilities which bleach chemical pulps with chlorine or chlorine derivatives: 1) cooperative agreement and 2) legal authorities such as 6308 under the Clean Hater Act and ?4 of the Tux?c Substances Control Act (TSCA). A cooperative agreement would obtain needed information from 135 mills and detailed dioxin formation and process modification data from a 25-mill subset of the group. The information will be supplied on a quick schedule, and industry will fund the total project including analyses, interlaboratory comparisons, and variability studies. EPA anticipates receiving all information within one year of the effective date of the agreement. EPA has Specified consistent sampling/analysis protocols and reporting methods to be used in data -2- collection. Therefore. data submitted will be of good quality if the mills comply with all agreement provisions. Because of the time factor, the cost of public dollars, and the willing- ness of industry representatives to provide additional, comprehensive dioxin information, EPA detennined that the c00perative approach was the most effective and timely way of obtaining the needed information and is in the public interest. Regional staff participated in the development of the agreement. If any facilities fail to cooperate. EPA will send ?308 letters to obtain the necessary information. The American Paper Institute (API), the trade associati0n of the pulp and paper industry, National Council of the Paper Industry for Air and Stream Improvement, Inc. (NCASI), an industry and research organization, and mill executives represented the industry in the development of the 5-mill study and the expanded cooperative dioxin study. EPA views industry involvement as necessary to the successful and timely completion of the expanded cooperative dioxin study. STUDY PROVISIONS 0 All mills using chlorine or chlorine derivatives to bleach chemical wood pulp (approximately 105) will provide the information detailed in the agreement. The study provides for the submittal of the following information by each participating mill: - all existing dioxin/furan analytical results - summary of effluent flow and analytical measurements for a one year period - wastewater treatment system schematic diagram - summary of present and past sludge diSposal practices - detailed bleaching process diagram and operating parameters - Dioxin/Furan analytical results for 5-day composite samples of effluents, sludges, and pulps; detailed process and sampling information during sampling period The study also provides for: - examination of a subset of samples for other chlorinated dioxin/furan isomers - inter-laboratory comparability studies for isomer specific dioxin analyses - detailed study of dioxin levels and bleaching processes at 25 mills - quarterly reports on NCASI research into dioxin presence in and migration out 0? paper products NOTIFICATION OF INTERESTED PARTIES EPA is transmitting an information collection request package to the Office of Management and Budget (OMB) for approval as required under the provisions of the Paperwork Reduction Act. This action is necessary before EPA can initiate the cooperative dioxin study. A Federal Register notice will be published which announces this transmittaT? complete ICR packages including the cooperative agreement can be obtained from EPA. However, all comments on this activity should be sent to ONE. The federal Register notice and this fact sheet will be sent to all interested parties ncluding industry groups, environmental groups, other federal agencies, congressional committees, labor groups, public interest groups, EPA Regional Administrative staff, and state personnel. If anyone has questions or wishes to meet with EPA staff concerning this study, they are directed to contact Tom O'Farrell, 0N/0ffice of Hater Regulations and Standards (0HRS)/Industrial Technology Division (ITD), at (202)382-7137. AVAILABILITY OF DATA will make all validated analytical results available to regional offices as soon as possible when received from NCASI (2-3 days after receipt). Regional offices will provide the information to the appropriate state agencies after receiving the data. A: tLat time, the Agency would consider the information to be available to the public. USE OF THE DATA will evalute effluent and sludge data to determine potential modifications to national effluent guidelines for the pulp and paper industry. will review process information to identify applicable treatment and control technologies. The Office of Hater Enforcement and Permits (OHEP) is currently drafting a permit strategy for control of dioxin discharges from bleached kraft mills. Permit writers will use data obtained in the cooperative study to determine which permit?modifications for dioxin are appropriate at these facilities. 5 '0 -4- use pulp data to support a risk assessment intended to characterize the fuii range of risks imposed by dioxin formation in bleached wood puip. Areas of concern inciude consumption of contaminated fish, exposure through migration of dioxin from food-grade and body contact paper products, disposai of contaminated siudges, other incidental exposure through use of paper products, and occupational exposure to puip and paper workers. 02/10/88 BACKGROUND DOCUMENT 1 REFERENCE DOSE DESCRIPTION AND USE IN HEALTH RISK ASSESSMENTS PRINCIPAL AUTHOR: Donald Barnes. (0PTS) WORK GROUP: Donald Barnes, (OPTS) 0 Judith Bellin, (OSWER) Christopher DeRosa. (0RD) Michael Dourson, (0RD), Co-Chair Reto Engler, (0PTS) Linda Erdreich. (0RD) Theodore Farber, (OPTS) Penny Fenner-Crisp, (0W) Elaine Francis, (0PTS) George Ghali. (0PTS) . Richard Hill, M.D., (0PTS) Stephanie Irene. (OPTS) - William Marcus, (OW) David Patrick, P.E., 8.8. (OAR) Susan Perlin, (OPPE) Peter Preuss. (0RD), Co-Chair Aggie Revesz, B.S. (OPTS) Reva Rubenstein, (OSWER) Jerry Stara, D.V.M., (0RD) Jeanette Wiltse, (0PTS) Larry Zaragosa. (OAR) 9?41: . CONTENTS 1.1. INTRODUCTION BACKGROUND AND SUMMARY 1.1.1. 1.1.2. OVERVIEW 1.2. TRADITIONAL APPROACH TO ASSESSING SYSTEMIC TOXICITY 1.2.1. DESCRIPTION OF THE TRADITIONAL APPROACH 1.2.2. SOME DIFFICULTIES IN UTILIZING THE TRADITIONAL APPROACH 1.2.2.1. Scientific Issues 1.2.2.2. Management-related Issues 12 2. 2. The use of the term "safety factor 12.2.2.2 The implication that any exposure in .- excess of the ADI is "unacceptable" and that any exposure less than the ADI is or "safe" '1 1.2.2.2.3. Possible limitations imposed on risk - management decisions up 1.2.2.2.4. Development of different ADIs by different programs 1.3. EPA ASSESSMENT OF RISKS ASSOCIATED WITH SYSTEMIC TOXICITY 1.3.1. HAZARD IDENTIFICATION 1.3.1.1. Evidence 1. 3.1. 1.1. Type of effect 1. 3. 1. l. 2. Principal studies l.3.1.1.2.l. Epidemiologic studies 1 1.2.2. Animal studies Supporting studies Route of exposure Length of exposure Quality of the study I muteu 1.3.1.2. Weight-of-Evidence Determination 1. 3 .2. DOSE-RESPONSE ASSESSMENT 1.3.2.1. Concepts and Problems 3 Selection of the Critical Data .2 2. 1. Critical study .2 2. 2. Critical data .2 2. 3. Critical endpoint thlh! 1.3.2.3. Reference Dose ii 1.5. 1.6. 1.7. 1.3.3 EXPOSURE ASSESSMENT 1.3.4. RISK CHARACTERIZATION APPLICATION IN RISK MANAGEMENT OTHER DIRECTIONS HYPOTHETICAL. SIMPLIFIED EXAMPLE OF DETERMINING AND USING .6.1. EXPERIMENTAL RESULTS .6.2. ANALYSIS 1.6.2.1. Determination of the Reference Dose .1. Using the NOAEL 2 Usin th LOAEL . 8 9 SEC I 27? 1.6.2.2. Risk Characterization Considerations REFERENCES l. REFERENCE DOSE DESCRIPTION AND USE IN HEALTH RISK ASSESSMENTS 1.1. INTRODUCTION This concept paper describes the U.S. Environmental Protection Agency?s (U 5. EPA) principal approach to and rationale for assessing risk for health effects other than cancer and gene mutations from chronic chemical exposure. By outlining principles and concepts that guide EPA risk assessment for such systemic effects the paper complements the new risk assessment guidelines (U.S. EPA, 1987), which describe the Agency's approach to risk assessment in other areas, specifically carcinogenicity, mutagenicity, developmental toxicity, exposure, and chemical mixtures. (In this document the term "systemic toxicity" refers to an effect other than carcinogenicity or mutagenicity induced by a toxic chemical.) 1.1.1. BACKGROUND AND SUMMARY ,Chemicals that give rise to toxic endpoints other than cancer and gene mutations are often referred to as "systemic toxicants" because of their effects on the function of various organ systems. In addition, chemicals that cause cancer and gene mutations also commonly evoke other toxic effects (1 systemic toxicity). Based on our understanding of homeostatic and adaptive mechanisms, systemic toxicity is treated as if there is an identifiable exposure threshold (both for the individual and for populations) below which there are no observable adverse effects. This characteristic distinguishes systemic endpoints from carcinogenic and mutagenic endpoints, which are often treated as nonthreshold processes. Systemic effects have traditionally been evaluated using such terms as "acceptable daily intake ''safety factor and "margin of safety concepts that are associated with certain limitations described below. The U.S. EPA established the Reference Dose Work Group to address these concerns. In preparing this report, the Work Group has drawn on traditional report on risk assessment (NRC, 1983), to more fully articulate the use of noncancer, nonmutagenic experimental data in reaching regulatory decisions about the significance of exposures to chemicals. In the process, the Work Group has coined less value-laden terminology -- l'reference dose "uhcertainty factor "margin of exposure and "regulatory dose -- to clarify and distinguish between aspects of risk assessment and risk management. These concepts are currently in general use in many parts of U.S. EPA. Section 1.2., the traditional approach to assessing risks of systemic toxicity is presented, and issues associated with this approach are identified and discussed. In Section 1.3., the modifications made to the traditional approach by the Work Group are presented. Section 1.4. examines how these new concepts can be applied in reaching risk management decisions, and Section 1.5. briefly discusses some of the additional approaches the U.S. EPA is using and exploring to address this issue. Section 1.6. provides a sample calculation. Section 1.7. consists of references. 1.2. TRADITIONAL APPROACH TO ASSESSING SYSTEMIC TOXICITY The U.S. EPA's approach to assessing the risks associated with systemic toxicity is different from its approach to assessing the risks associated with carcinogenicity, because of the different mechanisms of action thought to be involved in the two cases. In the case of carcinogens, the Agency assumes that a small number of molecular events can evoke changes in a single cell that can lead to uncontrolled cellular proliferation. This mechanism for carcinogenesis is referred to as 'nonthreshold,? since there is theoretically no level of exposure for such a chemical that does not pose a small, but finite, probability of generating a carcinogenic response. In the case of systemic toxicity, however, organic homeostatic, compensating, and adaptive mechanisms exist that must be overcome before a toxic endpoint is manifested. For example, there could be a large number of cells performing the same or similar function whose population must be significantly depleted before the effect is seen. The threshold concept is important in the regulatory context. The individual threshold hypothesis holds that a range of exposures from zero to some finite value can be tolerated by the organism with essentially no chance of expression of the toxic effect. Further, it is often prudent to focus on the most sensitive members of the population; therefore, regulatory efforts are generally made to keep exposures below the population threshold, which is defined as the lowest of the thresholds of the individuals within a population. 1.2.1. DESCRIPTION OF THE TRADITIONAL APPROACH In many cases, risk decisions on systemic toxicity have been made by the Agency using the concept of the "acceptable daily intake derived from an experimentally determined 'no-observed-adverse-effect level The ADI is commonly defined as the amount of a chemical to which a person can be exposed on a daily basis over an extended period of time (usually a lifetime) without suffering a deleterious effect. The ADI concept has'often been used as a tool in reaching risk management decisions establishing allowable levels of contaminants in foodstuffs and water.) A NOAEL is an experimentally determined dose at which there was no statistically or biologically significant indication of the toxic effect of concern. In an experiment with several NOAELs, the regulatory focus is normally on the highest one, leading to the common usage of the term NOAEL as the highest experimentally determined dose without a statistically or biologically significant adverse effect. The NOAEL for the critical toxic effect is sometimes referred to simply as the NOEL. This usage, however. invites ambiguity in that there may be observable effects that are not of toxicological significance they are not "adverse" . For the sake of precision, this document uses the term NOAEL to mean the highest NOAEL in an experiment. In cases in which a NOAEL has not been demonstrated experi- mentally, the term level is used. Once the critical study demonstrating the toxic effect of concern has been identified, the selection of the NOAEL results from an objective examination of the data available on the chemical in question. The ADI is then derived by dividing the appropriate NOAEL by a safety factor (SF), as follows: ADI (human dose) - NOAEL (experimental dose)/SF. (Equation 1) Generally, the SF consists of multiples of 10, each factor representing a specific area of uncertainty inherent in the available data. For example. a factor of 10 may be introduced to account for the possible differences in "'responsiveness between humans and animals in prolonged exposure studies. A second factor of 10 may be used to account for variation in susceptibility among individuals in the human population. The resultant SF of 100 has been judged to be appropriate for many chemicals. For other chemicals, with data bases that are less complete (for example, those for which only the results of subchronic studies are available), an additional factor of 10 (leading to a SF of'lQOO) might be judged to be more appropriate. For certain other chemicals. based on well-characterized responses in sensitive humans (as in the effect of fluoride on human teeth). an SF as small as 1 might be selected. While the original selection of SFs appears to have been rather arbitrary (Lehman and Fitzhugh. 1954), subsequent analysis of data (Dourson and Stara, 1983) lends theoretical (and in some instances experimental) support for their selection. Further, some scientists. but not all, within the EPA interpret the absence of widespread effects in the exposed human populations as evidence of the adequacy of the SFs traditionally employed. 1.2.2. SOME DIFFICULTIES IN UTILIZING THE TRADITIONAL APPROACH 1.2.2.1. Scientific Issues While the traditional approach has performed well over the years and the Agency has sought to be consistent in its application, observers have identfied scientific shortcomings of the approach. Examples include the following: a. Too narrow a focus on the NOAEL means that information on the shape of the dose-response curve is ignored. Such data could be important in estimating levels of concern for public safety. b. As scientific knowledge increases and the correlation of precursor effects enzyme induction) with toxicity becomes known. questions about the selection of the appropriate "adverse effect? arise. c. Guidelines have not been developed to take into account the fact that some studies have used larger (smaller) numbers of animals and, hence. are generally more (less) reliable than other studies. These and other "scientific issues" are not susceptible to immediate resolution, since the data base needed is not yet sufficiently developed or analyzed. U.S. EPA work groups are presently considering these issues. x. 1.2.2.2. Management-related Issues 1.2.2.2.1. The use of the term "safety factor" The term 'safety factor" suggests, perhaps inadvertently. the notion of absolute safety absence of risk). While there is a conceptual basis for believing in the existence of a threshold and "absolute safety" associated with certain chemicals, in the majority of cases a firm experimental basis for. this notion does not exist. 1.2 2.2.2. The implication that any exposure in excess of the ADI is ?unacceptable" and that any exposure less than the ADI is "acceptable" or 'safe' In practice, the ADI is viewed by many (including risk managers) as an "acceptable" level of exposure, and, by inference, any exposure greater than the ADI is seen as 'unacceptable.' This strict demarcation between what is "acceptable? and what is "unacceptable? is contrary to the views of most toxicologists, who typically interpret the ADI as a relatively crude estimate of a level of chronic exposure which is not likely to result in adverse effects to humans. The ADI is generally viewed by risk assessors as a "soft" estimate, whose bounds of uncertainty can span an order of magnitude. That is, within reasonable limits. while exposures somewhat higher than the ADI are associated with increased probability of adverse effects, that probability is not a certainty. Similarly, while the ADI is seen as a level at which the probability of adverse effects is low, the absence of all risk to all people cannot be assured at this level. 1.2 2.2.3. Possible limitations imposed on risk management decisions Awareness of the ?softness" of the ADI estimate, as discussed above, argues for careful case-by-case consideration of the toxicological implications of individual situation, so that ADIs are not given a degree of significance that is scientifically unwarranted. In addition, the ADI is only one factor in a risk management decision and should not be used to the exclusion of other relevant factors. 1.2.2.2.4. Development of different ADIs by different programs In addition to occasionally selecting different critical toxic effects, Agency scientists have reflected their best scientific judgments in the final ADI by adopting factors different from the standard factors listed in Table 1. For example, if the toxic endpoint for a chemical in experimental animals is the same as that which has been established for a related chemical in humans at similar doses, one could argue for an SF of less than the traditional 100. On the other hand, if the total toxicologic data base is incomplete, one could argue that an additional SF should be included, both as a matter of prudent public policy and as an incentive to others to generate the appropriate data. .4- TABLE 1 Guidelines for the Use of Uncertainty Factors in Deriving Reference Doses and Modifying Factors Use a 10-fold factor when extrapolating from valid experimental results in studies using prolonged exposure to average healthy humans. This factor is intended to account for the variation in sensitivity among the members of the human population and is referenced as Use an additional 10-fold factor when extrapolating from valid results of long- term studies on experimental animals when results of studies of human exposure are not available or are inadequate. This factor is intended to account for the uncertainty involved in extrapolating from animal data to humans and is referenced as Use an additional 10-fold factor when extrapolating from less than chronic results on experimental animals when there are no useful long-term human data. This factor is intended to account for the uncertainty involved in extrapolat- ing from less than chronic NOAELs to chronic NOAELs and is referenced as Use an additional 10-fold factor when deriving an from a LOAEL, instead of a NOAEL. This fact is intended to account for the uncertainty involved in extrapolating from AELs to NOAELs and is referenced as Modifying Factor (MP): Use professional judgment to determine the HF, which is an additional uncertainty factor that is greater than zero and less than or equal to 10. The magnitude of the HF depends upon the professional assessment of scientific uncertainties of the study and data base not explicitly treated above; the completeness of the overall data base and the number of species tested. The default value for the HF is l. *Source: Adapted from Dourson and Stars, 1985 Such practices. as employed by a number of scientists in different programs/agencies, exercising their best scientific judgment, have in some cases resulted in different ADIs for the same chemical. The fact that different ADIs were generated (for example, by adopting different SFs) can be a source of considerable confusion when the ADIs are used exclusively in risk management decisionmaking (see Section 1.2.2.2.3). The existence of different ADIs need not imply that any of them is more 'wrong'--or 'right'-othan the rest. It is more nearly a reflection of the honest difference in scientific judgment. However, on occasion, these differences in judgment of the scientific data, can be interpreted as differences in the management of the risk. As a result, scientists may be inappropriately impugned, and/or perfectly justifi- able risk management decisions may be tainted by charges of ''tampering with the science." This unfortunate state of affairs arises, at least in part, from treating the ADI as an absolute measure of safety. 1.3. EPA ASSESSMENT OF RISKS ASSOCIATED WITH SYSTEMIC TOXICITY The U.S. EPA approach to analyzing systemic toxicity data follow the general format set forth by NRC in its description of the risk assessment process (NRC, 1983). The determination of the presence of risk and its potential magnitude is made during the risk assessment process. which consists of hazard identification, dose-response assessment, exposure assessment. and risk characterization. Having been apprised by the risk that a potential risk exists, the risk manager considers control options available under existing statutes and other relevant non-risk factors benefits to be gained and costs to be incurred). All of these considerations go into the determination of the regulatory decision (Figure Hazard Identification Control Options I Dose-Response Assessment Non.risk Analyses Exposure Assessment I I I I - Risk Characterization >Regulatory Decision criterion) Standard) *Source: Adapted from NRC, 1983 1.3.1. HAZARD IDENTIFICATION 1.3.1.1. Evidence 1 3.1.1.1. Type of effect Exposure to a given chemical, depending on the dose employed, may result in a variety of toxic effects. These may range from gross effects, such as death, to more subtle biochemical, physiologic, or pathologic changes. In assessments of the risk posed by a chemical, the toxic endpoints from all available studies are considered, although primary attention usually is given to.the effect (the Icritical effect') exhibiting the lowest NOAEL. In the case of chemicals with limited data bases, additional toxicity testing may be necessary before an assessment can be made. 1.3.1.1.2. Principal studies Principal studies are those that contribute most significantly to the qualitative assessment of whether or not a particular chemical is potentially a systemic toxicant in humans. In addition, they may be used in the quantitative dose-response assessment phase of the risk assessment. These studies are of two types: studies of human populations (epidemiologic investigations) and studies using laboratory animals. l.3.l.l.2.l. Epidemiologic studies Human data are often useful in qualitatively establishing the presence of an adverse effect in exposed human populations. when there is information on the exposure level associated with an appropriate endpoint, epidemiologic studies can also provide the basis for a quantitative dose-response assessment. The presence of such data obviates the necessity of extrapolating from animals to humans: therefore, human studies. when available, are given first priority. with animal toxicity studies serving to complement them. In epidemiologic studies, confounding factors that are recognized can be controlled and measured, within limits. Case reports and acute exposures resulting in severe effects provide support for the choice of critical toxic effect. but they are often of limited utility in establishing a quantitative relationship between environmental exposures and anticipated effects. Available human studies on ingestion are usually of this nature. Cohort studies and clinical studies may contain exposure-response information that can be used in estimating effect levels. but the method of establishing exposure must be evaluated for validity and applicability. l.3.l.1.2.2. Animal studies For most chemicals. there is a lack of appropriate information on effects in humans. In such cases, the principal studies are drawn from experiments conducted on nonhuman mammals, most often the rat, mouse, rabbit, guinea pig, hamster, dog, or monkey. 1.3.1.1.3. Supporting studies These studies provide supportive, rather than definitive, information and can include data from a wide Variety of sources. For example, metabolic and other pharmacokinetic studies can provide insights into the mechanism of action of a particular compound. By comparing the metabolism of the chemical Similarly, in vitro studies can provide insights into the chemical's potential for biological activity; and under certain circumstances, considera- tion of structure-activity relationships betveen a chemical and other compounds can provide clues to the test chemical's pos- sible toxicity. Here reliable in vitro tests are presently being developed to minimize the need for live-animal testing. There is also increased emphasis on generating mechanism-of-action and pharmacokinetic information as a means of increasing understanding of toxic processes in humans and nonhumans. 1.3.1.1.h. Route of exposure The U.S. EPA often approaches the investigation of a chemical with a particular route of exposure in mind an oral exposure for a drinking water contaminant or an inhalation exposure for an air contaminant). In most cases. the toxicologic data base does not include detailed testing on all possible routes of administration, with their possibly significant differences in factors such.as mechanism-of-action and bioavailability. In general, the U.S. EPA's position is that the potential for toxicity manifested via one route of exposure is relevant to considerations of any other route of exposure, unless convincing evidence exists to the contrary. Consideration is given to potential differences in absorption or metabolism resulting from different routes of exposure, and whenever appropriate data comparative metabolism studies) are available, the quantitative impacts of these ?differences on the risk assessment are delineated. 1.3.1 1.5. Length of exposure The U.S. EPA is concerned about the potential toxic effects in humans associated with all possible exposures to chemicals. The magnitude, frequency, and'duration of exposure may vary considerably in different situations. Animal studies are conducted using a variety of exposure durations acute, subchronic, and chronic) and schedules single, intermittent, or continuous dosing). Information from all these studies is useful in the hazard identification phase of risk assessment. For example, overt neurological problems identified in high-dose acute studies tend to reinforce the observation of subtle neurological changes seen in low-dose chronic studies. Special attention is given to studies involving low-dose, chronic exposures, since such exposures can elicit effects absent in higher dose, shorter exposures, through mechanisms such as accumulation of toxicants in the organisms. 1 3.1.1.6. Quality'of the study Evaluation of individual studies in humans and animals requires the consideration of several factors associated with a study's hypothesis, design. execution, and interpretation. An ideal study addresses a clearly delineated hypOthesis, follows a carefully prescribed protocol, and includes sufficient subsequent analysis to support its conclusions convincingly. In evaluating the results from such studies, consideration is given to many other factors, including chemical characterization of the compound(s) under study, the type of test species, similarities and differences between the test Species and humans chemical absorption and metabolism), the number of individuals in the study groups, the number of study groups, the spacing and choice of dose levels tested, the types of observations and methods of analysis, the nature of pathologic changes, the alteration in metabolic responses, the sex and age of test animals, and the route and duration of exposure. 1.3.1.2. Weight-of-Evidence Determination As the culmination of the hazard identification step, a discussion of the weight-of-evidence summarizes the highlights of the information gleaned from the principal and supportive studies. Emphasis is given to examining the results from'different studies to determine the extent to which a consistent. plausible picture of toxicity emerges. For example, the following factors add to the weight of the evidence that the chemical poses a hazard to humans: similar results in replicated animal studies by different investigators; similar effects across sex, strain, species, and route of exposure; clear evidence of a dose-response relationship; a plausible relation between data on metabolism, postulated mechanism-of-action, and the effect of concern; similar toxicity exhibited by structurally related compounds; and some link between the chemical and evidence of the effect of concern in humanSLr 1.3.2. DOSE-RESPONSE ASSESSMENT 1.3.2.1. Concepts and Problems Empirical observations have generally revealed that as the dosage of a toxicant is increased, the toxic response (in terms of severity and/or incidence of effect) also increases. This dose-response relationship is well- founded in the theory and practice of toxicology and pharmacology. Such behavior is observed in the following instances: in quantal responses, in which the proportion of responding individuals in a population increases with dose; in graded responses, in which the severity of the toxic response within an individual increases with dose; and in continuous responses, in which changes in a biological parameter body or organ weight) vary with dose. In evaluating a dose-response relationship, certain difficulties arise. For example, one must decide on the critical endpoint to measure as the "response." One must also decide on the correct measure of "dose." In addition to the interspecies extrapolation aspects of the question of the appropriate units for dose, the more fundamental question of administered dose versus absorbed dose versus target organ dose should be considered. These questions are the subject of much current research. 1.3.2.2. Selection of the Critical Data 1.3.2.2.1. Critical study Data from experimental studies in laboratory animals are often selected as the governing information when performing quantitative risk assessments. since available human data are usually insufficient for this purpose. These animal studies typically reflect situations in which exposure to the toxicant has been carefully controlled and the problems of heterogeneity of the exposed population and concurrent exposures to other toxicants have been minimized. In evaluating animal data, a series of professional judgments are made which involve, among others, consideration of the scientific quality of the studies. Presented with data from several animal studies, the risk assessor first seeks to identify the animal model that is most relevant to humans, based on the most defensible biological rationale (e for instance using comparative pharmacokinetic data). In the absence of a clearly most relevant species, the most sensitive species the species showing a toxic effect at the lowest administered dose) is used by risk assessors at U.S. EPA, since there is no assurance that humans are not at least as innately sensitive as the most sensitive species tested. This selection process is more difficult when the routes of exposure in the animal tests are different from those involved in the human situation under investigation. In order to use data from controlled studies of genetically homogeneous animals, the risk assessor must also .10. extrapolate from animals to humans and from high experimental doses to comparatively low environmental exposures, and must account for human heterogeneity and possible concurrent human exposures to other chemicals. Although for most chemicals there is a lack of well?controlled cohort studies investigating noncancer endpoints, in some cases an epidemiologic study may be selected as the critical data in cases of cholinesterase inhibition). Risk assessments based on human data have the advantage of avoiding the problems inherent in interspecies extrapolation. In many instances, use of such studies, as is the case with animal investigations. involves extrapolation from relatively high doses (such as those found in occupational settings) to the low doses found in the environmental situations to which the general population is more likely to be exposed. In some cases, a well-designed and well-conducted epidemiologic study that shows no association between known exposures and toxicity can be used to directly project an (as has been done in the case of fluoride). 1.3.2.2.2. Critical data In the simplest terms. an experimental exposure level is selected from the critical study that represents the highest level tested in which "no adverse .effect" was demonstrated. This (NOAEL) is the key datum gleaned from the study of the dose-response relationship and, traditionally, is the primary basis for the scientific evaluation of the risk posed to humans by systemic toxicents. This approach is based on the assumption that if the critical toxic effect is prevented, then all toxic effects are prevented. More formally; the NOAEL is defined in this discussion as the highest experimental dose of a chemical at which there is no statistically or biologically significant increase in frequency or severity of an adverse effect in individuals in an exposed group when compared with individuals in an appropriate control group. As noted above. there may be sound professional differences of opinion in judging whether or not a particular response is adverse. In addition, the NOAEL is a function of the size of the population under study. Studies with a small number of subjects are less likely to detect low-dose effects than studies using larger numbers of subjects. Also, if the interval between doses in an experiment is large, it is possible that the experimentally determined NOAEL is lower than that which would be observed. in a study using intervening doses. 1.3.2 2.3. Critical endpoint As noted in Section 1.2.. a chemical may elicit more than one toxic effect (endpoint). even in one test animal, or in tests of the same or different duration (acute, subchronic. and chronic exposure studies). In general, NOAELs for these effects will differ. The critical endpoint used in the dose- response assessment is the effect exhibiting the lowest NOAEL. .11. 1.3.2.3. Reference Dose The reference dose and uncertainty factor (UF) concepts have been developed by the Work Group in response to many of the problems associated With ADIs and SFs, as outlined in Section 1.2. above. The is a benchmark dose operationally derived from the NOAEL by consistent application of generally order-of-magnitude uncertainty factors (UFs) that reflect various types of data sets used to estimate Rst. For example. a valid chronic animal NOAEL is normally divided by an UP of 100. In addition, a modifying factor (MP), is sometimes used which is based on a professional judgment of the entire data base of the chemical. These factors and their rationales are presented in Table l. The is determined by use of the following equation: - NOAEL (UF HF) which is the functional equivalent of Equation 1. In general, the is an estimate (with uncertainty spanning perhaps an order-of-magnitude) of a daily exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a. lifetime. The is generally expressed in units of milligrams per kilogram of bodyweight per day (mg/kg/day). The is useful as a reference point from which to gauge the potential effects of the chemical at other doses. Usually, doses less than the are not likely to be associated with adverse health risks, and'are therefore less likely to be of regulatory concern. As the frequency and/or magnitude of the exposures exceeding the increase, the probability of adverse effects in a human population increases. However, it should not be categorically concluded that all doses below the are "acceptable? (or will be risk-free) and that all doses in excess of the are "unacceptable? (or will result in adverse effects). . The U.S. EPA is attempting to standardize its approach to determining Rst. The Work Group has developed a systematic approach to summarizing its evaluations, conclusions, and reservations regarding in a "cover sheet" of a few pages in length. The cover sheet includes a statement on the confidence (high, medium, or low) the evaluators have in the stability of the High confidence indicates the judgment that the is unlikely to change in the future because there is consistency among the toxic responses observed in different sexes, species, study designs, or in dose-response relationships, or that the reasons for existing differences are well understood. High confidence is often given to that are based on human data for the exposure route of concern, since in such cases the problems of interspecies extrapolation have been avoided.. Low confidence indicates the judgment that the data supporting the may be of limited quality and/or quantity and that additional information could result in a change in the 1.3.3. EXPOSURE ASSESSMENT The third step in the risk assessment process focuses on exposure issues. For a full discussion of exposure assessment, consult U.S. EPA's guidelines on -12- the subject (U.S. EPA. 1987). In brief, the exposure assessment includes consideration of the size and nature of the populations exposed and the magnitude, frequency, duration and routes of exposure, as well as evaluation of the nature of the exposed populations. 1.3.4. RISK CHARACTERIZATION Risk characterization is the final step in the risk assessment process and the first input to the risk management (regulatory action) process. The purpose of risk characterization is to present the risk manager with a synopsis and of all the data that should contribute to a conclusion with regard to the nature and extent of the risk, including: a. The qualitative ("weight-of-evidence") conclusions as to the likelihood that the chemical may pose a hazard to human health. b. A discussion of the dose-response information considered in deriving the the including the UFs and used. c. Data on the shapes and slopes of the dose-response curves for the various toxic endpoints. toxicodynamics (absorption and metabolism), structure-activity correlations, and the nature and severity of the observed effects. d. Estimatps of the nature and extent of the exposure and the number and types of people exposed. e. of the overall uncertainty in the analysis, including the major assumptions made, scientific judgments employed, and an estimate of the degree of conservatism involved. In the risk characterization process. a comparison is made between the RED and the estimated (calculated or measured) exposure dose (EED). The EED should include all sources and routes of exposure involved. If the EED is less than the the need for regulatory concern is likely to be small. An alternative measure that may be useful to some risk managers is the margin of exposure (HOE). which is the magnitude by which the NOAEL of the critical.toxic effect exceeds the estimated exposure dose (EED), where both are expressed in the same units: need! NOAEL (experimental dose) EED (human dose). When the MOE is equal to or greater than UF the need for regulatory concern is likely t? be small. - Section 1.6. contains an example of the use of the concepts of NOAEL, UF, MF, EED. and MOE. 1.4. APPLICATION IN RISK MANAGEMENT Once the risk characterization is completed, the focus turns to risk management. In reaching decisions, the risk manager utilizes the results of .13- risk assessment, other technological factors, and legal, economic and social considerations in reaching a regulatory decision. These additional factors include efficiency, timeliness, equity. administrative simplicity, consistency, public acceptability. technological feasibility. and nature of the legislative mandate. Because of the way these risk management factors may impact different cases, consistent -- but not necessarily identical -- risk management decisions must be made on a case-by-case basis. For example, the Clean Water Act calls for decisions with ?an ample margin of safety"; the Federal Insecticide. Fungicide and Rodenticide Act (FIFRA) calls for "an ample margin of safety,? taking benefits into account; and the Safe Drinking Water Act (SDUA) calls for standards which protect the public "to the extent feasible." Consequently, it is entirely possible and appropriate that a chemical with a specific may be regulated under different statutes and situations through the use of different "regulatory doses (RgDs).' That is, after carefully considering the various risk and nonrisk factors. regulatory options. and statutory mandates in a given case the risk manager selects the appropriate statutory alternative for arriving at an "ample' or ?adequate"I margin of exposure As shown in Equation 2 below, this procedure establishes the regulatory dose, RgD(i) (e a tolerance under a maximum contaminant level under SDWA), applicable to the case in question: 3- . 1159(1) - NOAEL mom). (Equation 2) Note that different are possible for a given chemical with a single Note also that comparing the to a particular RgD(i) is equivalent to comparing the with the UP HF: . - - HF). In assessing the significance of a case in which the is greater (or less) than the the risk manager should carefully consider the case- specific data compiled by the risk assessors, as discussed in Section 1.3.A. In some cases. additional explanation and interpretation may be required from the risk assessors in order to arrive at a responsible and clearly articulated fihal decision on the i - It is generally useful to the risk manager to have i rmation regarding the contribution to the from various environmental me a air, water and food). Such information can provide insights that are_helpful in choosing among available control options. However. in cases in wh?ch site-specific criteria are being considered, local exposures through various media can often be determined more accurately than exposure estimates based upon generic approaches. In such cases, the exposure assessor's role is particularly important. For instance, at a given site, consumption of fish may clearly dominate the local exposure routes, while, on a national basis. fish consumption may play a minor role compared to ingestion of treated crops. Work is underway in the U.S. EPA to apportion the among the various environmental media. For example, consider the case of a food-use pesticide -14- which is a contaminant in drinking water. In selecting among risk management actions under the Safe Drinking Water Act. it might be prudent to assume an for drinking water purposes which is some fraction of the total Such an apportionment would explicitly acknowledge the possible additional exposure from ingestion of treated crops. The apportionment of the would. in general. provide additional guidance for risk managers of the various media- specific programs. 1.5. OTHER DIRECTIONS In addition to the development of reference doses. the U.S. EPA is pursuing other lines of investigation for systemic toxicity. For example, the Office of Air Quality Planning and Standards is using probabilistic risk assessment procedures for criteria pollutants. In this procedure, the population at risk is characterized, and the likelihood of the occurrence of various effects is predicted through the use of available scientific literature and of scientific experts' rendering their judgments concerning dose-response relationships. This dose-response information is then combined with the results of the exposure analysis to generate population risk estimates for alternative standards. Through the use of these procedures, decisionmakers are presented with ranges of risk estimates in which uncertainties associated with both the toxicity and exposure information are explicitly considered. The Office of Policy. Planning and Evaluation is investigating similar procedures in order to balance health risk and cost. In addition. scientists in the Office of Research and Development have initiated a series of studies designed to increase the reliability of risk assessments. They are investigating the use of extrapolation models as a means of estimating Rst, taking into account the statistical variability of the NOAEL and underlying UFs. 0RD is also exploring procedures for conducting health risk assessments that involve less. than-lifetime exposures. Finally, they are working on approaches to ranking the severity of different toxic effects. I?l.6. HYPOTHETICAL, SIMPLIFIED EXAMPLE OF DETERMINING AND USING 1.6.1. EXPERIMENTAL RESULTS Suppose the U28. EPA had a sound 90-day subchronic gavage study in rats with the data in Table 2: .15- TABLE 2 Hypothetical Data to Illustrate the Reference Dose Concept Dose Observation Effect Level ms/ks/day 0 Control--no adverse effects observed -- 1 No statistically or biologically NOEL significant differences between treated and control animals 5 2? decrease* in body weight gain (not NOAEL considered to be of biological significance); increased ratio of liver weight to body weight; histopathology indistinguishable from controls; elevated liver enzyme levels 25 201 decrease* in body weight gain; LOAEL increased* ratio of liver weight to body weight; enlarged, fatty liver with vacuole formation; increased* liver enzyme levels _3 *Statistically significant compared to controls. 1.6.2. ANALYSIS 1.6.2.1. Determination of the Reference Dose 1.6.2.2.1. Using the NOAEL Because the study is on animals and of subchronic duration, UF 3 101-! at 10A 2: 105 - 1000 (hue-1). In addition, there is a subjective adjustment (HF) based on the high number of animals (250) per dose group: 2 MP - 0.8. These factors then give UF MP - 800, so that an) - - 5/800 - 0.006 (mg/kg/day). .15- 1.6.2.1.2. Using the LOAEL If the NOAEL is not available. and if 25 mg/kg/day had been the lowest dose tested that showed adverse effects10,000 (Table 1). Using again the-subjective adjustment of HF - 0.8, one obtains Rio - HF) - 25/3000 - 0.003 (mg/kg/day). 1.6.2.2. Risk Characterization Considerations Suppose the estimated exposure dose (EED) for humans exposed to the chemical under the proposed use pattern were 0.01 mg/kg/day the EED is greater than the Viewed alternatively(mg/kg/day) 0.01 (mg/kg/day) - 500. Because the BED exceeds the (and the HOE is less than the UP MP), the risk manager will need to look carefully at the data set, the assumptions for both the and the exposure estimates, and the comments of the risk assessors. In addition, the risk manager will need to weigh the benefits associated with the case, and other non-risk factors, in reaching a decision on the regulatory dose 1.7. REFERENCES Dourson, M.L. and J.F. State. 1983. Regulatory Toxicology and Pharmacology. 3: 224-238. Lehman, A.J. and 0.6. Fitzhugh. 195h. Association of Food Drug Officials. USQ Bull. 18: 33-35. NRC (National Research Council). 1983. Risk Assessment in the Federal Government: Managing the Process. HAS Press, Washington. DC. U.S. EPA. 1987. The Risk Assessment Guidelines of 1986. Office of Health and Environmental Assessment, Washington, DC. .17.